ACETAMINOPHEN AND DIPHENHYDRAMINE HCL - acetaminophen and diphenhydramine hcl tablet 
Carilion Materials Management

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acetaminophen and Diphenhydramine HCl Captabs

Active Ingrdient

(in each captab)

PURPOSE

Pain Reliever/Sleep Aid

Uses

Temporarily relieves 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

Directions

adults and children 12 years or over:

childrens under 12 years do not use

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.

QUESTIONS

Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

Acetaminophen/Diphenhydramine

Label Image
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL  
acetaminophen and diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0703(NDC:0536-3479)
Route of AdministrationORAL
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AP;133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-0703-01 in 1 PACKAGE; Type 0: Not a Combination Product10/06/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/06/2010
Labeler - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-0703)

Revised: 12/2017
Document Id: 23007611-e51a-4f28-b3e9-66ab545a5ced
Set id: e7af7a8d-8a64-42ff-a120-114fb9451ee3
Version: 5
Effective Time: 20171226
 
Carilion Materials Management