ALLERGY- diphenhydramine hydrochloride tablet, film coated 
Kroger Company

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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160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets

DRUG FACTS

Diphenhydramine HCl 25 mg

Antihistamine

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

temporarily relieves these symptoms due to the common cold:

Warnings
Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

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

Keep out of reach ot children. In case of overdose, get medical help or contact a Poison Control Center right away(l-800-222-1222).

Directions

adults and children 12 years of age and over 1 to 2 caplets
children 6 to under 12 years of age 1 caplet
children under 6 years of age do not use this product in children under 6 years of age

OTHER INFORMATION

Other information

Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Questions or comments?

1-800-632-6900

Allergy 400ct Carton

Allergy 400ct Carton

Allergy 400ct Label

Allergy 400ct label

Allergy 100ct Carton

Allergy 100ct Carton

Allergy 100ct label

Allergy 100 label

Allergy 24ct Carton

Allergy 24ct Carton

ALLERGY 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code T;061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-160-421 in 1 CARTON05/11/2021
112 in 1 BLISTER PACK
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41226-160-401 in 1 CARTON05/11/2021
2400 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41226-160-011 in 1 CARTON05/11/2021
3100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/11/2021
Labeler - Kroger Company (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(41226-160)

Revised: 4/2021
Document Id: bfc02efe-894c-40be-e053-2995a90aaaae
Set id: bc019c9e-8fac-5fd3-e053-2a95a90a7ccd
Version: 2
Effective Time: 20210412
 
Kroger Company