Diphenhydramine Oral Liquid description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine Oral Liquid

Rij Pharmaceutical Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient in each 5 mL ( in one teaspoonful)

Diphenhydramine HCl, USP HCl 12.5 mg.

Purpose

Antihistamine

Diphenhydramine Oral Liquid 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

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet

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 machiney
  • 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.

Directions

  • take every 4-6 hours
  • Do not use more than 6 times in 24 hours
adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years ask a doctor

Diphenhydramine Oral Liquid Other information

  • •store at room temperature 15º - 30ºC (59º - 86ºF)
  • •protect from freezing.
  • •protect from light.
  • •each teaspoon (5 mL) contains: sodium 16 mg
  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive ingredients

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

PRINCIPAL DISPLAY PANEL

Diphenhydramine Oral Liquid

Diphenhydramine Oral Liquid

Diphenhydramine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53807-204
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
SODIUM BENZOATE
SODIUM CITRATE
saccharin sodium
sorbitol
SUCROSE
water

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53807-204-04 118 in 1 BOTTLE
2 NDC:53807-204-08 236 in 1 BOTTLE
3 NDC:53807-204-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1999-03-16


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Be sure to consult your doctor before taking any medication!
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