ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE- acetaminophen and diphenhydramine hydrochloride tablet 
Granules India Limited

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Acetaminophen 500mg Diphenhydramine HCl 25mg Tablets

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:

DO NOT USE

ASK A DOCTOR

before use if you have

ASK A DOCTOR OR PHARMACIST

before use if you are

WHEN USING

this product

STOP USE

and ask a doctor if

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

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

apap-500mg-pouch-jpgapap-500mg-drum-jpgAPAP PMbbbf09f2-figure-01

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-661
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeOVAL (caplet-shaped) Size17mm
FlavorImprint Code G651
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-661-78125000 in 1 DRUM12/05/2014
2NDC:62207-661-9477670 in 1 DRUM06/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/05/2014
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-661)

Revised: 2/2023
Document Id: f4dec699-8d5e-53fc-e053-2995a90a411e
Set id: 1aff2e0d-95a8-420a-adc1-8b44b8a7178c
Version: 5
Effective Time: 20230216
 
Granules India Limited