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Drug Facts
Cvs Pharmacy Pre-measured Spoon Childrens
FDA Label NDC 59779-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Pharmacy Pre-measured Spoon Childrens (NDC 59779-044). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml)*, purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 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
Principal Display Panel (Childrens 01)
* Please review the disclaimer below.
