Active Ingredients (In Each 5 Ml)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Nighttime Cold And Cough Liquid
FDA Label NDC 63941-984
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Best Choice (valu Merchandisers Company) for the product Nighttime Cold And Cough (NDC 63941-984). 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
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 sedatives 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 a 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= milliliter
- shake well before using
| Age | Dose |
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | 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
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough
Children's Triacting Night Time Cold & Cough
Diphenhydramine HCl 6.25 mg
Antihistamine / Cough Suppressant
Phenylephrine HCl 2.5 mg
Nasal Decongestant
Multi-symptom relief
- Cough
- Runny, stuffy nose
- Itchy throat
For Ages 6 to 11 years
Alcohol-free
Grape Flavor
FL OZ (mL)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Children's Triaminic® Night Time Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.
5000 KANSAS AVE, KANSAS CITY, KS 66106
Package Label
BEST CHOICE Children's Triacting Night Time Cold & Cough Grape Flavor
* Please review the disclaimer below.
