FDA Label for Daytime Nighttime Cold And Cough Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS DAYTIME (IN EACH 5 ML)
- ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 5 ML)
- PURPOSES FOR DAY TIME
- PURPOSE FOR NIGHT TIME
- 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
- PRODUCT LABEL
Daytime Nighttime Cold And Cough Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 Daytime (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Active Ingredients For Nighttime (In Each 5 Ml)
Diphenhydramine HCl 6.25 mg
Phenylephrine HCl 2.5 mg
Purposes For Day Time
Cough suppressant
Nasal decongestant
Purpose For Night Time
Antihistamine/Cough suppressant
Nasal decongestant
Uses
DAYTIME
- temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
- 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
NIGHTTIME
Do Not Use
DAYTIME
- 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.
- in a child under 4 years of age
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs 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
NIGHTTIME
Ask A Doctor Before Use If The Child Has
DAYTIME
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- 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
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If The Child Is
NIGHTTIME
taking sedatives or tranquilizers.
When Using This Product
DAYTIME
do not use more than directed.
NIGHTTIME
- 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
DAYTIME
- nervousness, dizziness or sleeplessness occur
- 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.
- nervousness, dizziness, or sleeplessness occur
- 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.
NIGHTTIME
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
DAYTIME
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
NIGHTTIME
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
DAYTIME
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
- shake well before using
- 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
age | dose |
children 6 to under 12 years of age | 10 mL every 4 hours |
children 4 to 5 years | 5 mL every 4 hours |
children under 4 years | do not use |
NIGHTTIME
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 of age | do not use |
Other Information
DAYTIME
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68°-77°F). Do not refrigerate.
- each 5 mL contains: sodium 3 mg
- store between 20-25°C (68-77°F). Do not refrigerate
- protect from light
NIGHTTIME
Inactive Ingredients
Inactive ingredients for Day Time
acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate
Inactive ingredients for Night Time
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® Day Time Cold & Cough*
Children's
Cold & Cough
DEXTROMETHORPHAN HBr Cough suppressant
PHENYLEPHRINE HCI Nasal decongestant
Relieves
- Cough
- Stuffy nose
- Cough
- Runny, stuffy nose
- itchy throat
Alcohol 0.14%
For Ages 4 to 11 Years
Cherry Flavor
Dosage cup included
FL OZ (mL)
Compare to the active ingredients in Children's Triaminic® Night Time Cold & Cough
Children's
Nighttime Cold & Cough
DIPHENHYDRAMINE HCI Antihistamine; Cough suppressant
PHENYLEPHRINE HCI Nasal decongestant
Relieves
Alcohol free
For Ages 6 to 11 Years
Grape Flavor
Dosage cup included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Children's Triaminic® Day Time & Night Time Cold & Cough.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
Product Label
CVS HEALTH Children's DayTime NightTime Cold & Cough
* Please review the disclaimer below.