ALLERGY RELIEF- diphenhydramine hydrochloride tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Health Pharma USA LLC. 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:  

     o Runny nose

     o Sneezing

     o Itchy, watery eyes

     o Itchy nose or throat

• Temporarily relieves these symptoms of the common cold:

    o Runny nose
    o Sneezing

Warnings

Do not use

• With any other product containing diphenhydramine, even one used on skin
• To make a child sleepy

Ask a doctor before use if you have

• Trouble urinating due to an enlarged prostate gland
• Glaucoma 
• A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

When using this product

• Marked drowsiness may occur
• Avoid alcoholic drinks
• Excitability may occur, especially in children 
• Alcohol, sedatives and tranquilizers may increase drowsiness
• Be careful 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 accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Take every 4 to 6 hours, or as directed by a doctor

Do not take not more than 6 doses in 24 hours

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

Other Information

• Each caplet contains: Calcium 23.52 mg
• Store between 20-25°C (68-77°F)
• Protct from light

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

Inactive Ingredients

May Contains:

Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, film coaat AMB pink, Polyethylene Glycol, Polyvinyl Alcohol, Phloxine B lake, Titanium dioxide, Talc

Questions or comments?

Call 1-844-832-1138

9 AM- 4 PM Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride 25 mg/Antihistamine

Compare to Benadryl ®  Allergy active ingredients*

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl ®Allergy.

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71679-106
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	D25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71679-106-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2012
2	NDC: 71679-106-06	600 in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2012
3	NDC: 71679-106-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/12/2012

Labeler - Health Pharma USA LLC (080804485)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(71679-106)