DRUG FACTS

Active ingredients (in each caplet)
Diphenhydramine HCl 25 mg

Purpose
Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• itchy, watery eyes
• sneezing
• itchy nose or throat
temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing

Warnings

Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
• glaucoma
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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

When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
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
• each caplet contains: calcium 25 mg
• protect from light
• store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

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? Call 1-800-824-1706

Monday - Friday 9 am-4pm MST

160R-Winco-Allergy-Relief-bottle-label-100s 160R-Winco-Allergy-Relief-carton-label-100s

COMPLETE ALLERGY RELIEF
diphenhydramine hcl 25mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-381
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	T;061
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67091-381-24	1 in 1 CARTON	01/15/2022
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:67091-381-10	1 in 1 CARTON	01/15/2022
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/15/2022

Labeler - WinCo Foods LLC (056098817)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC.		037052099	manufacture(67091-381)

160R Winco Foods 67091 381 Diphenhydramine HCl 25 mg 24ct and 100ct

DRUG FACTS