ACETAMINOPHEN tablet, extended release

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP,  650 mg

PURPOSE

Pain reliever/fever reducer

USES

For Arthritis Pain label
 temporarily relieves minor aches and pains due to:
     minor pain of arthritis
     muscular aches
     backache
     premenstrual and menstrual cramps
     the common cold
     headache
     toothache
 temporarily reduces fever

For Muscle Aches & Pain label
 temporarily relieves minor aches and pains due to:
     muscular aches
     backache
     minor pain of arthritis
     toothache
     premenstrual and menstrual cramps
     headache
     the common cold
 temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take
 more than 6 caplets in 24 hours, which is the maximum daily amount
 with other drugs containing acetaminophen
 3 or more alcoholic drinks everyday while using this product

Allergy alert: acetaminophen may cause severe skin reactions
Symptoms may include:
 skin reddening
 blisters 
 rash
If a skin reaction occurs, stop use and seek medical help right away

Do not use

 with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
 if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are 

taking the blood thinning drug warfarin.

Stop use and ask doctor if

   pain gets worse or lasts more than 10 days
   fever gets worse or lasts more than 3 days
   new symptoms occur
   redness or swelling is present
These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or contact a poison control center right away.(1-800 222-1222).  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

DIRECTIONS

For Arthritis Pain Label
  do not take more than directed (see overdose warning)

• adults: take 2 caplets every 8 hours with water ; swallow whole; do not crush, chew, split or dissolve ; do not take more than 6 caplets in 24 hours ; do not use for more than 10 days unless directed by a doctor
• under 18 years of age: ask a doctor

For Muscle Ache and Pain label
 do not take more than directed (see overdose warning)

• adults and children 12 years of age and over: take 2 caplets every 8 hours with water ; swallow whole; do not crush, chew, split or dissolve ; do not take more than 6 caplets in 24 hours ; do not use for more than 10 days unless directed by a doctor
• children under 12 years: do not use

OTHER INFORMATION

 store between 20-25°C (68-77°F)
 do not use if foil inner seal is broken or missing.

INACTIVE INGREDIENTS

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

QUESTIONS OR COMMENTS ?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-188
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G650
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-188-51	1 in 1 CARTON	04/18/2019
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62207-188-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211544	04/18/2019

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-183
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G650
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-183-51	1 in 1 CARTON	04/18/2019
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62207-183-34	1 in 1 BOX	06/30/2019
2		5 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 62207-183-87	1 in 1 BOX	06/30/2019
3		1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 62207-183-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211544	04/18/2019

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (918609236)