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 Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

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

• runny nose
• sneezing
• itchy nose or throat
• itchy, watery eyes

Warnings

Do not use

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

ASK DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

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

Drug Facts continued on back of label

WHEN USING

When using this product

• you may get very drowsy
• avoid alcoholic drinks
• alcohol, sedatives, & 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 breat-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 helo or contact a Poison Control Center right away.

Directions

• take every 4-6 hours
• do not take more than 6 doses in 24 hours

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

Other information

• each caplet contains: calcium 45 mg
• store at room temperature
• protect from moisture

Inactive ingredients

croscarmellose sodium, D&C red #27, dicalcium phosphate, HPMC, magnesium stearate, microcrystalline cellulose, PEG, titanium dioxide

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pmET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BENADRYL®

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 69618-025-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPLETS

*Compare to Active Ingredient in BENADRYL® ALLERGY

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-025
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)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	AP;135
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-025-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)