Childrens Cold And Cough Liquid
FDA Label NDC 21130-379

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Childrens Cold And Cough (NDC 21130-379). 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 active ingredients (in each 5 ml), purposes, uses, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each 5 Ml)

→ Purposes

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If The Child Has

→ Ask A Doctor Or Pharmacist Before Use If The Child Is

→ When Using This Product,

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

→ Package Label

Active Ingredients (In Each 5 Ml)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCI 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Uses

temporarily relieves
- sneezing
- runny nose
- itchy nose or throat
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritations as may occur with a cold

Do Not Use

in a child under 4 years of age
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other product containing diphenhydramine, even one used on skin
for the purpose of making your child sleepy

Ask A Doctor Before Use If The Child Has

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough that occurs with too much phlegm (mucus)
chronic cough that lasts, or as occurs with asthma
a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedative or tranquilizers.

When Using This Product,

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days or occur with a fever
cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Do not give more than 6 doses in 24 hours unless directed by a doctor.
measure only with dosing cup provided Do not use any other dosing device
keep dosing cup with product
mL=mililiter

Age	Dose
children 6 to under 12 years	10 mL every 4 hours
children 4 to under 6 years	do not use unless directed by a doctor
children under 4 years	do not use

Other Information

each 5 mL contains: sodium 3 mg
store between 20°-25°C (68°-77°F). Do not refrigerate.
protect from light

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate