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


1033921 - Front 3

1033922 - Back 4


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



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


3178


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.


NA


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



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)


Strength

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool

62 x 55 mm


1033

921

3179



62 x 55 mm 238 g

1033921

NA



NA


NA

1.0


No Varnish ZoneLOT:

EXP:


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



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)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


Manufactured by: Strides Shasun Limited Bengaluru - 560076, India


Revised: 01/2017

3180



62 x 55 mm 238 g

1033922

NA


NA


NA

1.1




NDC 59556-762-05

Polyethylene Glycol 3350Polyethylene Glycol 3350Powder for SolutionPowder for SolutionOsmotic LaxativeOsmotic Laxative



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


Strength

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool

82 x 78 mm


1033

923

3181



82 x 78 mm 510 g

1033923

NA



NA


NA

1.0


No Varnish ZoneLOT:

EXP:


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



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


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:


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


Revised: 01/2017Manufactured by: Strides Shasun Limited Bengaluru - 560076, India




82 x 78 mm 510 g

1033924

NA


NA


NA

1.1


3182



table of contents glycol 3350 powder for solution.pdfosmotic laxative 7 once-daily doses •...

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