OTC Medication Information: ACETAMINOPHEN

ACETAMINOPHEN- acetaminophen tablet, extended release
Granules Pharmaceuticals Inc.

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 Labeldo 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-label-100-count-jpg
(click image for full-size original)

ACETAMINOPHEN acetaminophen tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70010-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POVIDONE K30
STARCH, CORN
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A CORN
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G650
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70010-160-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211544 02/15/2022
Labeler — Granules Pharmaceuticals Inc. (079825711)
Registrant — Granules India Limited (915000087)

Revised: 08/2022 Granules Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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