DIPHENHYDRAMINE HYDROCHLORIDE tablet, coated

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Time-Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

(in each caplet)

Diphenhydramine Hcl 25 mg

ASK DOCTOR

Ask a doctor before use if you have

glaucoma;

trouble urinating due to an enlarged prostate gland;

a breathing problem such as emphysema or chronic bronchitis

ASK DOCTOR/PHARMACIST

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

DO NOT USE

Do not use

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

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.

WARNINGS

Warnings

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

PREGNANCY OR BREAST FEEDING

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

PURPOSE

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

runny nose; itchy water eyes sneezing;itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

WHEN USING

When using this product

Avoid alcoholic drinks

marked drowsiness may occur

Alcohol, sedatives, and tranquilizers may increase drowsiness

Excitability may occur, especially in children

Be careful when driving a motor vehicle or operating machinery

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-329
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	7mm
Flavor		Imprint Code	help
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-329-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2010

Labeler - Time-Cap Labs, Inc (037052099)

Registrant - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs, Inc		037052099	manufacture(49483-329)