CORRECT DOSE- diphenhydramine hydrochloride liquid

Correct Dose by

Drug Labeling and Warnings

Correct Dose by is a Otc medication manufactured, distributed, or labeled by BFS Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = one pre-filled spoon

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

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)

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

INGREDIENTS AND APPEARANCE

CORRECT DOSE   CHILDRENS ALLERGY RELIEF
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76103-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
D&C red NO. 33 (UNII: 9DBA0SBB0L)
FD&C red NO. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
glycyrrhizin, ammoniated (UNII: 3VRD35U26C)
poloxamer 407 (UNII: TUF2IVW3M2)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium chloride (UNII: 451W47IQ8X)
sodium citrate (UNII: 1Q73Q2JULR)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2011

Labeler - BFS Pharma, Inc. (967271458)