Table of Contents glycol 3350 powder for solution.pdfOsmotic Laxative 7 ONCE-DAILY DOSES •...
Transcript of Table of Contents glycol 3350 powder for solution.pdfOsmotic Laxative 7 ONCE-DAILY DOSES •...
Table of Contents
Polyethylene Glycol 3350, Powder for Solution, 17 grams/capful and 17
grams/packet (OTC) 1
Container Label (119 grams/can) 1
1033919 - Front 1
1033920 - Back 2
Container Label (238 grams/can) 3
1033921 - Front 3
1033922 - Back 4
Container Label (510 grams/can) 5
1033923 - Front 5
1033924 - Back 6
NDC 59556-762-03
NET WT 4.15 OZ
(119 g)
Original Prescription
StrengthPolyethylene Glycol 3350Polyethylene Glycol 3350Powder for SolutionPowder for SolutionOsmotic LaxativeOsmotic Laxative
Polyethylene Glycol 3350Powder for SolutionOsmotic Laxative
7ONCE-DAILYDOSES
• Relieves Occasional Constipation (Irregularity)• Softens Stool• Dissolves in any beverage• Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL
UNDER CAP IS MISSING, OPEN OR BROKEN
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
54 x 32 mm
1033919 CL-PEG-3350, OTC-FRONT-119g-SPI, USA CONTAINER LABEL-[54x32mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][FRONT LABEL][119g][SPI, USA][KRSG][ENG][3177]
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL ( FRONT)
54 x 32 mm 119 g
1033919
NA
PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.0
6PANTONE 268 C PANTONE Yellow C PANTONE Red 032 C PANTONE 340 C BLACK SILVER HOT FOIL STAMPING
103
3919
3177
Drug Facts (continued)Inactive ingredients none
Questions or comments? 1-877-244-9825
Revised: 01/2017
Manufactured by: Strides Shasun Limited Bengaluru - 560076, India
Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Other informationŸ store at 20° to 25°C (68° to
77°F)Ÿ tamper-evident: do not
use if foil seal under cap, printed with "SEALED for YOU PROTECTION"is missing, open or broken
Drug FactsActive ingredient (in each dose) PurposePolyethylene Glycol 3350,17 g (cap filled to line)....................Osmotic Laxative
LOT:
EXP: No Varnish Zone
Code No.: KR/DRUGS/KTK/25/415/98
1033920
Pee
l her
e
Drug Facts (continued)
Ask a doctor or pharmacist before use if you are taking a prescription drugŸ When using this product you may
have loose, watery, more frequent stools
Stop use and ask a doctor ifŸ you have rectal bleeding or your
nausea, bloating, cramping or abdominal pain gets worse. These
may be signs of a serious condition.Ÿ you get diarrheaŸ you need to use a laxative for longer
than 1 weekIf pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Drug Facts (continued)Drug Facts (continued)
DirectionsŸ do not take more than directed
unless advised by your doctorŸ the bottle top is a measuring
cap marked to contain 17grams of powder when filled to the indicated line (white section in cap)
Ÿ adults and children 17 years of age and older:
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a doctor before use if you have Ÿ nausea, vomiting or abdominal
painŸ a sudden change in bowel
habits that lasts over 2 weeksŸ irritable bowel syndrome
Drug Facts (continued)Drug Facts (continued)
Drug Facts (continued)
UseŸ relieves occasional
constipation (irregularity)Ÿ generally produces a bowel
movement in 1 to 3 days
WarningsAllergy alert: Do not use if you are allergic to polyethylene glycol
Ÿ children 16 years of age or under: ask a doctor
Ÿ fill to top of white section in cap which is marked to indicate the correct dose(17g)
Ÿ stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
Ÿ use once a dayŸ use no more than 7 days
Drug Facts (continued)
3178
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL (BACK)
54 x 32 mm 119 g
1033920
NA
BASE LABEL: PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.LEAFLET: 90 GSM art paper with spot aqueous varnish.
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.1
2PANTONE 268 C BLACK
1033920 CL-PEG-3350, OTC-BACK-119g-SPI, USA CONTAINER LABEL-[54x32mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][BACK LABEL][119g][SPI, USA][KRSG][ENG][3178]
NDC 59556-762-04
Polyethylene Glycol 3350Polyethylene Glycol 3350Powder for SolutionPowder for SolutionOsmotic LaxativeOsmotic Laxative
Polyethylene Glycol 3350Powder for SolutionOsmotic Laxative
• Relieves Occasional Constipation (Irregularity)• Softens Stool• Dissolves in any beverage• Sugar Free
14ONCE-DAILYDOSES
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP
IS MISSING, OPEN OR BROKEN
NET WT 8.3 OZ
(238 g)
Original Prescription
Strength
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool
62 x 55 mm
1033921 CL-PEG-3350, OTC-FRONT-238g-SPI, USA CONTAINER LABEL-[62x55mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][FRONT LABEL][238g][SPI, USA][KRSG][ENG][3179]
1033
921
3179
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL ( FRONT)
62 x 55 mm 238 g
1033921
NA
PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.0
6PANTONE 268 C PANTONE Yellow C PANTONE Red 032 C PANTONE 340 C BLACK SILVER HOT FOIL STAMPING
No Varnish ZoneLOT:
EXP:
Code No.: KR/DRUGS/KTK/25/415/98
Pee
l her
e1033922
Drug FactsActive ingredient (in each dose) PurposePolyethylene Glycol 3350, 17 g (cap filled to line) Osmotic Laxative
Use• relieves occasional constipation (irregularity)• generally produces a bowel movement in 1 to 3 days
WarningsAllergy alert: Do not use if you are allergic to polyethylene glycol
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a doctor before use if you have • nausea, vomiting or abdominal pain• a sudden change in bowel habits that lasts
over 2 weeks • irritable bowel syndrome
Ask a doctor or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
Stop use and ask a doctor if• you have rectal bleeding or your nausea, bloating,cramping or abdominal pain gets worse. These may besigns of a serious condition.
• you get diarrhea• you need to use a laxative for longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• do not take more than directed unless advised by your
doctor• the bottle top is a measuring cap marked to contain
17 grams of powder when filled to the indicated line (white section in cap)
• adults and children 17 years of age and older: • fill to top of white section in cap which is marked to
indicate the correct dose (17 g)
Drug Facts (continued)Drug Facts (continued)
Drug Facts (continued)
Drug Facts (continued)Ÿ • stir and dissolve in any 4 to 8 ounces of
beverage (cold, hot or room temperature) then drink
Ÿ • use once a dayŸ • use no more than 7 days
• children 16 years of age or under: ask a doctor
Other information• store at 20° to 25°C (68° to 77°F)• tamper-evident: do not use if foil seal under cap,
printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive ingredients none
Questions or comments? 1-877-244-9825
Manufactured by: Strides Shasun Limited Bengaluru - 560076, India
Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Revised: 01/2017
3180
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL (BACK)
62 x 55 mm 238 g
1033922
NA
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.1
2PANTONE 268 C BLACK
1033922 CL-PEG-3350, OTC-BACK-238g-SPI, USA CONTAINER LABEL-[62x55mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][BACK LABEL][238g][SPI, USA][KRSG][ENG][3180]
BASE LABEL: PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.LEAFLET: 90 GSM art paper with spot aqueous varnish.
NDC 59556-762-05
Polyethylene Glycol 3350Polyethylene Glycol 3350Powder for SolutionPowder for SolutionOsmotic LaxativeOsmotic Laxative
Polyethylene Glycol 3350Powder for SolutionOsmotic Laxative
• Relieves Occasional Constipation (Irregularity)• Softens Stool• Dissolves in any beverage• Sugar Free
NET WT 17.9 OZ
(510 g)
30ONCE-DAILYDOSES
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP
IS MISSING, OPEN OR BROKEN
Original Prescription
Strength
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool
82 x 78 mm
1033923 CL-PEG-3350, OTC-FRONT-510g-SPI, USA CONTAINER LABEL-[82x78mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][FRONT LABEL][510g][SPI, USA][KRSG][ENG][3181]
1033
923
3181
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL ( FRONT)
82 x 78 mm 510 g
1033923
NA
PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.0
6PANTONE 268 C PANTONE Yellow C PANTONE Red 032 C PANTONE 340 C BLACK SILVER HOT FOIL STAMPING
No Varnish ZoneLOT:
EXP:
Code No.: KR/DRUGS/KTK/25/415/98
1033924
Drug Facts
Active ingredient (in each dose) PurposePolyethylene Glycol 3350, 17 g (cap filled to line)…...Osmotic Laxative
UseŸ relieves occasional constipation (irregularity)Ÿ generally produces a bowel movement in 1 to 3 days
WarningsAllergy alert: Do not use if you are allergic to polyethylene glycol
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a doctor before use if you have Ÿ nausea, vomiting or abdominal painŸ a sudden change in bowel habits that lasts over 2 weeksŸ irritable bowel syndrome
Pee
l her
e
Drug Facts (continued)
Ask a doctor or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
Ÿ Stop use and ask a doctor ifŸ you have rectal bleeding or your nausea, bloating,
cramping or abdominal pain gets worse. These may be signs of a serious condition.
Ÿ you get diarrheaŸ you need to use a laxative for longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DirectionsŸ do not take more than directed unless advised by your
doctorŸ the bottle top is a measuring cap marked to contain 17
grams of powder when filled to the indicated line (white section in cap)
Ÿ adults and children 17 years of age and older:
Drug Facts (continued)
Ÿ fill to top of white section in cap which is marked to indicate the correct dose (17 g)
Ÿ stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
Ÿ use once a dayŸ use no more than 7 daysŸ children 16 years of age or under: ask a doctor
Other informationŸ store at 20° to 25°C (68° to 77°F)Ÿ tamper-evident: do not use if foil seal under cap,
printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive ingredients none
Questions or comments? 1-877-244-9825
Revised: 01/2017Manufactured by: Strides Shasun Limited Bengaluru - 560076, India
Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
POLYETHYLENE GLYCOL, 3350
STRIDES PHARMA INC FIX-A-FORM - LABEL (BACK)
82 x 78 mm 510 g
1033924
NA
Colour shades to be matched as per Pantone Shade only. Printing clarity to be clear and sharp.
NA
Self adhesive labels in Roll-form with Rounded Corners
NA
1.1
2PANTONE 268 C BLACK
3182
1033924 CL-PEG-3350, OTC-BACK-510g-SPI, USA CONTAINER LABEL-[82x78mm][POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION][OTC][BACK LABEL][510g][SPI, USA][KRSG][ENG][3182]
BASE LABEL: PSA Label Stock. 80 GSM paper (Raflatac / Avery Dennison) 16 - 22 GSM adhesive / 62 GSM release paper / Aqueous varnish.LEAFLET: 90 GSM art paper with spot aqueous varnish.