DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet

Diphenhydramine Hydrochloride 25mg by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride 25mg by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine HCl 25mg

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

DOSAGE & ADMINISTRATION

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

• adults and children 12 years of age and over: take 1 to 2 caplets
• children 6 to under 12 years: take 1 caplet
• children under 6 years of age: do not use

INDICATIONS & USAGE

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

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

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

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

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

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

PURPOSE

Antihistamine

OTHER SAFETY INFORMATION

• store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
• avoid excessive heat, cold and humidity

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
diphenhydramine hydrochloride 25mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-136
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)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	D25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-136-22	12 in 1 PACKAGE; Type 0: Not a Combination Product	11/23/2020
2	NDC: 70692-136-01	100 in 1 PACKAGE; Type 0: Not a Combination Product	12/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/20/2018

Labeler - Strive Pharmaceuticals Inc (080028013)