creomulsion for children soothing cough syrup drug facts

creomulsion for children soothing cough syrup drug facts
SPL v10
SPL
SPL Set ID 39d0e96c-1cc3-4961-e054-00144ff88e88
Route
oral
Published
Effective Date 2016-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg)
Inactive Ingredients
caramel citric acid monohydrate corn syrup fd&c red no. 40 menthol potassium sorbate water sodium benzoate sucrose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-08-11

Purpose

Cough Suppressant

Description

In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg


Medication Information

Warnings

Do not use if you are now taking 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 a pharmacist before taking the product.

Uses
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Purpose

Cough Suppressant

Directions
  • Do not take more than 6 doses in any 24 period. Use enclosed dose cup.
Children 6 years to under 12 years 10mL (2tsp) every 4 hours
Children 2 to under 6 years 5mL (1tsp) every 4 hours
Children under 2 years Do not use

Other Information
  • store at 20-25°C (68-77°F)
  • packaged with tamper evident seal around cap
  • contains no alcohol
Inactive Ingredients

caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose

Description

How Creomulsion For Children Works?

Gentle Creomulsion For Children is specially formulated for a child's delicate system. It contains the most effective cough suppressant available without a prescription. It calms the urge to cough, while Creomulsion's smooth consistency soothes your child's throat.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient

In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg

Questions Or Comments

Call 8am - 4pm Est. Mon - Fri. 1-404-566-8896

Money Back Guarantee

Guaranteed to give desired results or your money back.

Send carton top, reason for dissatisfaction, sales receipt, lot number, and your phone number to Socius Care, LLC

3939 Royal Dr. NW, Suite 230, Kennesaw, GA 30144

Image of Carton and Label

Stop Use and Ask A Doctor If

  • cough lasts more than 7 days comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If You
  • have cough that occurs with too much phlegm (mucus)
  • have cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Structured Label Content

Warnings

Do not use if you are now taking 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 a pharmacist before taking the product.

Uses
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Purpose

Cough Suppressant

Directions
  • Do not take more than 6 doses in any 24 period. Use enclosed dose cup.
Children 6 years to under 12 years 10mL (2tsp) every 4 hours
Children 2 to under 6 years 5mL (1tsp) every 4 hours
Children under 2 years Do not use

Other Information
  • store at 20-25°C (68-77°F)
  • packaged with tamper evident seal around cap
  • contains no alcohol
Inactive Ingredients

caramel, citric acid, corn syrup, FD and C Red No. 40, flavor, menthol, potassium sorbate, purified water, sodium benzoate, sucrose

Description (34089-3)

How Creomulsion For Children Works?

Gentle Creomulsion For Children is specially formulated for a child's delicate system. It contains the most effective cough suppressant available without a prescription. It calms the urge to cough, while Creomulsion's smooth consistency soothes your child's throat.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient

In one teaspoon (5 ml) Dextromethorphan HBr, USP 5 mg

Questions Or Comments (Questions or Comments)

Call 8am - 4pm Est. Mon - Fri. 1-404-566-8896

Money Back Guarantee

Guaranteed to give desired results or your money back.

Send carton top, reason for dissatisfaction, sales receipt, lot number, and your phone number to Socius Care, LLC

3939 Royal Dr. NW, Suite 230, Kennesaw, GA 30144

Image of Carton and Label

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • cough lasts more than 7 days comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have cough that occurs with too much phlegm (mucus)
  • have cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Advanced Ingredient Data


Raw Label Data

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