ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet

Acetaminophen and Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Acetaminophen and Diphenhydramine Hydrochloride by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

(in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25mg

PURPOSE

Pain reliever

Nighttime sleep aid

USES

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

DO NOT USE

• with any other drug containing acetaminophen (prescription or nonprescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients

ASK A DOCTOR

before use if you have

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

ASK A DOCTOR OR PHARMACIST

before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

WHEN USING

this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery

STOP USE

and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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

Directions

• do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours
• children under 12 years:
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-661
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL (caplet-shaped)	Size	17mm
Flavor		Imprint Code	G651
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-661-78	125000 in 1 DRUM	12/05/2014
2	NDC: 62207-661-94	77670 in 1 DRUM	06/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/05/2014

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-661)