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

croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide

DOSAGE & ADMINISTRATION

• take with a full glass of water
• do not take more than directed

• adults and children 12 years of age and over: 2 caplets at bedtime if needed, or as directed by a doctor
• children under 12 years of age: do not use

INDICATIONS & USAGE

for relief of occasional sleeplessness

WARNINGS

Do not use

• in children under 12 years of age
• 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

• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

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

Nighttime sleep-aid

OTHER SAFETY INFORMATION

• store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
• avoid high humidity
• protect from light

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
diphenhydramine hydrochloride 25mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-111
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
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TALC (UNII: 7SEV7J4R1U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-111-41	4 in 1 PACKAGE; Type 0: Not a Combination Product	12/20/2018
2	NDC: 70692-111-01	100 in 1 PACKAGE; Type 0: Not a Combination Product	01/29/2019

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)