ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hydrochloride tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by PLD Acquisitions LLC DBA Avéma Pharma Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active 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
  • itching of the nose or throat
• temporarily relieves these symptoms due to 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 prostate gland

Ask a doctor or pharmacist before use if you are

taking 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

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. (1-800-222-1222)

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 and over: take 1 to 2 tablets
• children 6 to under 12 years: take 1 tablet
• children under 6 years: do not use

Other information

• each tablet contains: calcium 25 mg
• store between 20-25°C (68-77°F)
• protect from light and moisture

Inactive ingredients

croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Principal Display Panel

Compare to the active ingredient in Benadryl® Allergy**

Allergy Relief

Diphenhydramine HCl 25 mg Antihistamine

Relieves

• Runny Nose
• Sneezing
• Itchy,Watery Eyes
• Itchy Nose or Throat

Tablets

**This product is not manufactured or distributed by McNeil Consumer Healthcare,distributor of Benadryl ® Allergy

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Allergy Relief

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63548-0690
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)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	V;25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63548-0690-1	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/02/2010

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)