Drugplain

Childrens Cold and Cough Nighttime 6.25 mg/5mL

Diphenhydramine HCl, Phenylephrine HCl · LIQUID · Safeway, Inc.

No Recall History
Plain English

Childrens Cold and Cough Nighttime is a liquid containing diphenhydramine hcl, phenylephrine hcl at 6.25 mg/5mL, taken oral. Manufactured by Safeway, Inc..

Key Facts

Brand Name
Childrens Cold and Cough Nighttime
Generic Name
Diphenhydramine HCl, Phenylephrine HCl
NDC Code (Product)
21130-379
Manufacturer
Safeway, Inc.
Strength
6.25 mg/5mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/31/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nasopharyngitis1 reports
sciatica1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal or chest congestion or sore throat with accompanying occasional sleeplessness.

Dosage & Administration

Directions Shake well before using. Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter. Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night or as necessary Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night or as necessary

Warnings

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if Symptoms persist for more than 7 days or worsen. Inflammation, fever or infection develops. Symptoms are accompanied by a high fever (over 101°F). Cough tends to recur or is accompanied by a high fever, rash or persistent headache. Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. In case of emergency contact a medical professional or Poison Control Center immediately.

Frequently Asked Questions

What is Childrens Cold and Cough Nighttime used for?

Childrens Cold and Cough Nighttime contains Diphenhydramine HCl, Phenylephrine HCl. It is a liquid taken oral. Consult your doctor for specific uses.

Is Childrens Cold and Cough Nighttime a controlled substance?

Childrens Cold and Cough Nighttime is not classified as a controlled substance by the DEA.

What is the generic name for Childrens Cold and Cough Nighttime?

The generic name for Childrens Cold and Cough Nighttime is Diphenhydramine HCl, Phenylephrine HCl. There are 8 other brand versions of Diphenhydramine HCl, Phenylephrine HCl.

What is the NDC code for Childrens Cold and Cough Nighttime 6.25 mg/5mL?

The NDC (National Drug Code) for Childrens Cold and Cough Nighttime 6.25 mg/5mL is 21130-379, listed by Safeway, Inc..