Your browser does not support JavaScript! ALLERGY RELIEF ANTIHISTAMINE (DIPHENHYDRAMINE HCL) TABLET [MCKESSON (SUNMARK)]
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ALLERGY RELIEF ANTIHISTAMINE (diphenhydramine hcl) tablet
[Mckesson (Sunmark)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 of 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

  • 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 operating machinery or driving a motor vehicle

  • excitability may occur, especially in children

If pregnant of 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
  • do not more than 6 doses in 24 hours
 adults and children 12 years of age and over 1 to 2 tablets 
 children 6 to under 12 years of age 1 tablet
children under 6 years of agedo not use this product in children under 6
 children under 4 years of age do not use

Other information

  • each tablet contains: calcium 25mg/ tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, *lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, *polyvinyl alcohol, *purified water, *talc, and titanium dioxide

* Contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Allergy Relief

Antihistamine

For the temporary relief of:

sneezing, itchy & watery eyes, runny nose & itchy throat

Diphenhydramine HCl 25 mg

Compare to Benadryl® Allergy ultratab® Active Ingredient*

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

Sunmark Allergy Relief

Diphenhydramine HCl 25 mg

 

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-983
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
EGG PHOSPHOLIPIDS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code T;61;V;25;S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-983-042 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:49348-983-101 in 1 BOX
2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33609/28/2011
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
 
Mckesson (Sunmark)

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