CAREONE CHILDRENS COLD COUGH BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE RETAIL BUSINESS SERVICES, LLC FDA Approved Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing
FunFoxMeds box
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid edetate disodium FD&C blue no. 1 FD&C red no. 40 flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sorbitol solution
Strengths
10 ml 2 mg 10 mg
Quantities
118 ml
Treats Conditions
Uses Temporarily Relieves Cough Runny Nose Sneezing Itching Of The Nose Or Throat Itchy Watery Eyes Due To Hay Fever Or Other Upper Respiratory Allergies Temporarily Alleviates The Intensity Of Coughing

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
IXA7C9ZN03 9D2RTI9KYH
Packaging

Package/Label Principal Display Panel CAREone ® Compare to the active ingredients in Children’s Dimetapp ® Cold & Cough Safe and Effective Relief without Phenylephrine For Ages 6 and Older Children’s COLD & COUGH Antihistamine – Brompheniramine Maleate, 2 mg Cough Suppressant – Dextromethorphan HBr, 10 mg FOR RELIEF OF: • Runny Nose • Itchy, Watery Eyes • Coughing & Sneezing • Alcohol Free Gluten Free Grape Flavor 4 FL OZ (118 mL) careone-childrens-cold-&-cough-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel CAREone ® Compare to the active ingredients in Children’s Dimetapp ® Cold & Cough Safe and Effective Relief without Phenylephrine For Ages 6 and Older Children’s COLD & COUGH Antihistamine – Brompheniramine Maleate, 2 mg Cough Suppressant – Dextromethorphan HBr, 10 mg FOR RELIEF OF: • Runny Nose • Itchy, Watery Eyes • Coughing & Sneezing • Alcohol Free Gluten Free Grape Flavor 4 FL OZ (118 mL) careone-childrens-cold-&-cough-carton-image.jpg

Overview

Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing

Indications & Usage

Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing

Dosage & Administration

Directions • do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use

Warnings & Precautions
Warnings Do not use • 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 make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • 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 cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away (1-800-222-1222).
Purpose

Purposes Antihistamine Cough suppressant

Do Not Use

Do not use • 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 make a child sleepy

When Using

When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • 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 & Ask a Doctor

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Questions

Questions or comments? 1-800-719-9260


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