ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated 
TIME CAP LABORATORIES, INC

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.

----------

160R timely 49483-061 Diphenhydramine HCl 25mg

DRUG FACTS

Active ingredient (in each caplet)
Diphenhydramine HCI 25 mg

Purpose
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 of children. In case of accidental overdose, get medical help or contact a Poison Control Centre (1-800-222-1222) right away.

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 no 27 aluminum lke, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol(PEG)400, polysorbate80, titanium dioxide.

Questions or comments?call 1-877-290-4008

160R-timely-365s-label160R-timely-24s-label160R-timely-24s-ifctimely 160R Diphenhydramine HCl 25mg bottle label 650ct
160label

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-061
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code T061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-061-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
2NDC:49483-061-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
3NDC:49483-061-62650 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
4NDC:49483-061-421 in 1 CARTON07/30/2021
424 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:49483-061-65365 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-061)

Revised: 2/2023
Document Id: f4b5e5bc-c56b-bb42-e053-2995a90a0b09
Set id: 7aee34b5-1583-4a8a-8ffb-b17ef2722ac1
Version: 8
Effective Time: 20230214
 
TIME CAP LABORATORIES, INC