CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION- diphenhydramine hydrochloride liquid

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).

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 a sealed pouch. Do not use if individual foil pouch is 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?

Call 877-545-3635

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Benadryl® Allergy Perfect Measure
PRINCIPAL DISPLAY PANEL
NDC: 59779-044-10

CVS Pharmacy Pre-measured spoon
Children's
ALLERGY LIQUID MEDICATION®

Diphenhydramine HCI
Oral Solution Antihistamine

Relieves:
- Sneezing
- Runny Nose
- Itchy, watery eyes
- Itchy Throat
Cherry Flavored

Alcohol Free

10 PRE-FILLED SINGLE USE SPOONS**
0.17 FL OZ (5 mL) EACH

CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION
diphenhydramine hydrochloride liquid

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	08/25/2011

Labeler - CVS PHARMACY, INC. (062312574)

CVS Pharmacy Pre-measured spoon Childrens by