DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl tablet

Diphenhydramine HCl 25 mg by

Drug Labeling and Warnings

Diphenhydramine HCl 25 mg by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (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 an 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

• avoid alcoholic drinks
• marked drowsiness may occur; alcohol, sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• use caution 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 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: 1 or 2 caplets
    • children 6 to under 12 years: 1 caplet
    • children under 6 years: do not use this product for 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 or comments?

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Package Label

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-990
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 RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	pink	Score	score with uneven pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	T;061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-990-30	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/10/2018

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Medline Industries, Inc.		079800021	repack(53329-990)