ALLERGY RELIEF- diphenhydramine hydrochloride tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by SAM'S WEST INC, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Diphenhydramine HCl 25 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

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

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing

WARNINGS

Warnings

DO NOT USE

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

ASK DOCTOR

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

WHEN USING

When using this product

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours

• adults and children 12 years and over: 1 to 2 tablets
• children 6 to under 12 years: 1 tablet
• children under 6 years: do not use

OTHER SAFETY INFORMATION

Other information

• each tablet 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 INGREDIENT

Inactive ingredientscarnauba 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

Questions or comments?

Call 1-877-290-4008 9:00 AM-5:00 PM ET, Monday-Friday

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-160
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-160-60	600 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2024

Labeler - SAM'S WEST INC (051957769)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(68196-160)