Allergy Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Allergy Relief

SIMPLY RIGHT (Sam's West, Inc.)
P and L Development of New York Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves 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 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 take more than 6 doses in 24 hours
 adults and children 12 years of age and over  take 1 to 2 tablets 
 children 6 to under 12 years of age  take 1 tablet
 children under 6 years of age  do not use this product in children under 6

Other information

  • each tablet contains: calcium 25 mg/tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture

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 1-888-301-0332 Monday-Friday 8AM-5PM CST

Principal Display Panel

allergy relief

diphenhydramine

hydrochloride 25 mg | antihistamine

Compare to Benadryl® Allergy Ultratab® active ingredient**

for allergy relief

sneezing       itchy, watery eyes

runny nose    itchy throat or nose

tablets

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

Distributed by:

SAM'S WEST, INC.,

BENTONVILLE, AR  72716

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

Product Label
Simply Right Diphenhydramine HCl 25 mg Allergy Relief

Allergy Relief

Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68196-690
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
polysorbate 80
POLYVINYL ALCOHOL
talc
titanium dioxide
ALUMINUM OXIDE
EGG PHOSPHOLIPIDS
water

Product Characteristics

Color Size Imprint Code Shape
PINK 12 mm T61;V25;S4 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 400 in 1 BOTTLE, PLASTIC
2 NDC:68196-690-04 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2011-10-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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