FDA Label for Childrens Cold And Cough Nighttime
View Indications, Usage & Precautions
- 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
Childrens Cold And Cough Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Safeway, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Questions Or Comments?
Call 1-888-723-3929 Monday-Friday 7AM-6PM PST
Principal Display Panel
FOR AGES 6-11 YEARS
Nighttime Childrens's Cold & Cough Relief
Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant
Phenylephrine HCl 2.5 mg - Nasal Decongestant
GRAPE FLAVOR
- Relief of: Cough, itchy throat, runny & stuffy nose
- Dosing cup included
FL OZ (mL)
Compare to Children's Triaminic® Night Time Cold & Cough active ingredients*
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis, distributors of Children's Triaminic® Night Time Cold & Cough.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Package Label
* Please review the disclaimer below.