FDA Label for Daytime And Nighttime Cough And Chest Congestion Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS DAY TIME (IN EACH 5 ML)
- ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 10 ML)
- PURPOSES FOR DAY TIME
- PURPOSE FOR NIGHT TIME
- USES
- DO NOT US
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Daytime And Nighttime Cough And Chest Congestion 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 Day Time (In Each 5 Ml)
Dextromethorphan HBr USP 5 mg
Guaifenesin. USP 100 mg
Active Ingredients For Nighttime (In Each 10 Ml)
Chlorpheniramine maleate, USP 2 mg
Dextromethorphan HBr USP 15 mg
Purposes For Day Time
Cough suppressant
Expectorant
Purpose For Night Time
Antihistamine
Cough suppressant
Uses
DAYTIME
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:• runny nose• sneezing• itching of the nose or throat• itchy, watery eyes
NIGHTTIME
Do Not Us
DAYTIME
• 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.• 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.
NIGHTTIME
Ask A Doctor Before Use If You Have
DAYTIME
• cough that occurs with too much phlegm (mucus)• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema• trouble urinating due to an enlarges prostate gland• glaucoma• a cough that occurs with too much phlegm (mucus)• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
NIGHTTIME
taking sedatives or tranquilizers.
When Using This Product
NIGHTTIME
• 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
DAYTIME
• cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.• cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
NIGHTTIME
If Pregnant Or Breast-Feeding,
DAYTIME
ask a health professional before use.
NIGHTTIME
ask a health professional before use
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
• measure only with dosing cup provided.• keep dosing cup with product• mL= milliliter• do not take more than 6 doses in any 24-hour period• measure only with dosing cup provided.• keep dosing cup with product• mL= milliliter• do not take more than 4 doses in any 24-hour period
age | dose |
Children under 4 years | Do not use |
Children 4 to under 6 years | 5 mL every 4 hours |
Children 6 to under 12 years | 10 mL every 4 hours |
Adults and children 12 years and older | 20 mL every 4 hours |
NIGHTTIME
age | dose |
Children under 6 years | Do not use |
Children 6 to under 12 years | 10 mL every 6 hours |
Adults and children 12 years and older | 20 mL every 6 hours |
Other Information
DAYTIME
• each 5 mL contains: sodium 3 mg• store at room temperature. Do not refrigerate• contain low sodium• do not use if printed seal under cap is torn or missing• each 10 mL contains: sodium 3 mg• store at room temperature. Do not refrigerate• contain low sodium• do not use if printed seal under cap is torn or missing
NIGHTTIME
Inactive Ingredients
Inactive ingredients for Day Time
anhydrous citric acid, edetate disodium, FD &C Blue # 1, FD&C Red # 40, natural and artificial flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Inactive ingredients for Night Time
anhydrous citric acid, FD&C Red # 40, natural and artificial flavors, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Children's Robitussin® Cough & Chest Congestion DM*
Non-Drowsy
Children's
Cough & Chest Congestions DM
Each 5 mL dose of oral solution contains:
DEXTROMETHORPHAN HBr, USP 5 mg
Cough suppressant
GUAIFENESIN, USP 100 mg
Expectorant
Relieves
• Chest congestion/mucus• Cough• Cough up to 8 hours• Runny nose
For Ages 4 and over
Grape Flavor
Naturally and Artificially Flavored
Dosage cup included
TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)
Compare to the active ingredients in Children's Robitussin® Nighttime Cough DM*
NDC# 69842-657-08
Children's
Nighttime Cough DM
Each 10 mL dose of oral solution contains:
CHLORPHENIRAMINE MALEATE, USP 2 mg
Antihistamine
DEXTROMETHORPHAN HBr, USP 15 mg
Cough suppressant
Relieves
Alcohol free
For Ages 6 & over
Fruit Punch Flavor
Naturally and Artificially Flavored
Dosage cup included
TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)
*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin® Cough + Chest Congestion DM and Children’s Robitussin® Nighttime Cough DM.
Distributed by: CVS Pharmacy, Inc.
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