Cold and Congestion Childrens Nighttime
Cold and Congestion Childrens Nighttime is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL manufactured by Walgreens administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231009.
Generic: DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL
Manufacturer: Walgreens
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 0363-0058
Application: M012
Effective: 20231009
Active Ingredients: Active ingredients (in each 10 mL) Diphenhydramine HCI 12.5 mg Phenylephrine HCI 5 mg
Indications & Usage
Uses temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies nasal congestion cough runny nose sneezing itchy, watery eyes itching of the nose or throat
Dosage & Administration
Directions do not take more than 6 doses in any 24-hour period do not exceed recommended dosage measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use
Contraindications
Not available.
Warnings
Warnings Do not use to sedate a child or to make a child sleepy if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlem (mucus) a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed 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 Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with a fever cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. 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 (1-800-222-1222) right away.
Adverse Reactions
Not available.
More from same ingredient
No related products.