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Correct Dose

BFS Pharma, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon

Purpose

Antihistamine

Correct Dose 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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 machinery
  • 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 (1-800-222-1222).

Directions

  • refer to chart below
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
Children under 2 years of age do not use
Children 2 to 5 years of age do not use unless directed by a doctor
Children 6 to 11 years of age 1 to 2 pre-filled spoons (12.5 mg to 25 mg)
Adults and children 12 years of age and over 2 to 4 pre-filled spoons (25 mg to 50 mg)

Correct Dose Other information

  • each pre-filled spoon contains: sodium 14 mg
  • store between 20-25°C (68-77°F).
  • Protect from light. Store in outer carton until contents used.
  • SAFETY SEALED: This product is protected by sealed pouches. Do not use if individual pouches are torn or damaged

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

1-877-545-3635

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributo of Children's Benadryl® Allergy Perfect Measure

PRINCIPAL DISPLAY PANEL

NDC 76103-004-10

Correct Dose
Children's
Allergy Relief
®


Diphenhydramine HCI
Oral Solution Antihistamine

Correct Dose HELPS RELIEVE

  • Sneezing
  • Runny Nose
  • Itchy Eyes & Throat
  • Watery Eyes

CHERRY FLAVOR

Alcohol Free

10 PRE-FILLED SINGLE USE SPOONS**
0.17 FL OZ (5 mL) EACH
**12.5 mg Diphenhydramine HCl each

Correct Dose

Correct Dose

Diphenhydramine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76103-004
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
GLYCERIN
GLYCYRRHIZIN, AMMONIATED
POLOXAMER 407
water
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SUCROSE

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 POUCH
2 NDC:76103-004-10 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-15


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