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

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Diphenhydramine Hydrochloride

Physicians Total Care, Inc.

Hydramine Liquid 0182-6168-40


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each teaspoon (5 mL))

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Diphenhydramine Hydrochloride 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

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

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 2 to 4 teaspoons (25 mg to 50 mg)
children 6 to under 12 years ask a doctor
children 4 to 5 years do not use unless directed by a doctor
children under 4 years do not use

Diphenhydramine Hydrochloride Other information

  • each teaspoon (5 mL) contains: sodium 5 mg
  • store between 20°-25°C (68°-77°F). Protect from light.

Inactive ingredients

artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

PRINCIPAL DISPLAY PANEL


NDC 54868-1227-0

Diphenhydramine Hydrochloride

TAMPER-EVIDENT


Diphenhydramine HCl USP
12.5 mg per 5 mL)

ONE PINT (473 mL)

ANTIHISTAMINE

ALCOHOL-FREE
SUGAR-FREE
CHERRY-FLAVORED

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

NOT FOR HOUSEHOLDS
WITH YOUNG CHILDREN


Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-1227(NDC:0182-6168)
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
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C Red no. 40
GLYCERIN
POLYSORBATE 20
water
SODIUM BENZOATE
SACCHARIN SODIUM DIHYDRATE
SODIUM CITRATE
sorbitol

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-1227-0 473 in 1 BOTTLE, PLASTIC
2 NDC:54868-1227-2 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-10-22


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