CAREONE TUSSIN- dextromethorphan hydrobromide solution

careone tussin by

Drug Labeling and Warnings

careone tussin by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 10 mL)

Dextromethorphan HBr, USP 30 mg

Purpose

Cough suppressant

Use

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

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)

Directions

• do not take more than 4 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• age:

  dose

• adults and children 12 years and over:

  10 mL

  every 6 to 8 hours

• children under 12 years:

  do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Robitussin® Long-Acting Cough

TUSSIN LONG ACTING COUGH

Cough Suppressant – Dextromethorphan HBr

Relieves Cough For Up to 8hrs

Adult

For Ages 12 & Over

Non-Drowsy

1.4% ALCOHOL

Gluten Free

OUR PHARMACISTS RECOMMEND

Original Flavor

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

CAREONE TUSSIN 
dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-903
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-903-26	1 in 1 CARTON	02/08/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/08/2018

Labeler - American Sales Company (809183973)