ACETAMINOPHEN- acetaminophen tablet, extended release 
Granules India Limited

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Acetaminophen Extended Release Tablets 650 mg

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

acetaminophen-er-650mg-bulk-jpgacetaminophen-label2-jpgacetaminophen-label1-jpgacetaminophen-label2acetaminophen-label3acetaminophen-label4acetaminophen-eracetaminophen-650mgacetaminophen-650mg-label1.jpg

ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-188
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-188-511 in 1 CARTON04/18/2019
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62207-188-491000 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154404/18/2019
ACETAMINOPHEN 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-183
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-183-511 in 1 CARTON04/18/2019
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62207-183-341 in 1 BOX06/30/2019
25 in 1 POUCH; Type 0: Not a Combination Product
3NDC:62207-183-871 in 1 BOX06/30/2019
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:62207-183-491000 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
5NDC:62207-183-9740000 in 1 DRUM; Type 0: Not a Combination Product03/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154404/18/2019
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (918609236)

Revised: 4/2021
Document Id: c0a28196-1336-69c9-e053-2995a90a2ccd
Set id: 00eb3e4b-1507-4c9a-83a5-ef50cb312753
Version: 6
Effective Time: 20210423
 
Granules India Limited