ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

runny nose
sneezing
itchy, watery eyes
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 DOCTOR

Ask a doctor before use if you have

• glaucoma
• troble 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 aretaking sedatives or tranquilizers.

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

PREGNANCY

If pregnant or breast-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 help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• if needed, repeat dose every 4 to 6 hours
• do not take more than 6 times in 24 hours
• adults and children 12 years of age or older - 1 to 2 caplets
• children 6 to under 12 years - 1 caplet
• children under 6 years of age - do not use.

Other information

each tablets contains:

calcium 15 mg
store between 20-25°C (68-77°F). Avoid high humidity

Inactive ingredients

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

Questions or comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:
Pioneer Life Sciences
40E Cotters Lane, Suite A
East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl 25 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-021
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-021-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/31/2018

Labeler - Pioneer Life Sciences, LLC (014092742)