trispec dmx pediatric drops cough suppressant expectorant cherry raspberry flavor

trispec dmx pediatric drops cough suppressant expectorant cherry raspberry flavor
SPL v1
SPL
SPL Set ID 95f910b0-1bab-4826-868a-a9d0148f23c2
Route
oral
Published
Effective Date 2014-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (187 mg)
Inactive Ingredients
citric acid monohydrate glycerin methylparaben ammonium glycyrrhizate potassium citrate potassium sorbate propylparaben propylene glycol water sorbitol sucralose

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-02-27

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 187 mg


Medication Information

Warnings



Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Cough suppressant

Expectorant

Directions
  • For children under 6 years of age, use enclosed dropper
  • do not use enclosed dropper for any other drug product

Children 2 to under 6 years of age:

2.5 mL every 4 hours not to exceed 15 mL in 24 hours, or as directed by a doctor

Children under 2 years of age:

Consult a doctor.

Other Information
  • Store at room temperature 15°C-30°C (59°F-86°F)

Inactive Ingredients

cherry flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 187 mg

Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Do Not Use



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.

Stop Use and Ask A Doctor If
  • cough persists for more than 1 week, tends to recur, 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.

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

Ask A Doctor Before Use If the Child Has
  • persistent or chronic cough such as occurs with asthma
  • cough accompanied by excessive phlegm (mucus)

Active Ingredients (in Each 5 Ml Teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor



Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor 2oz/60ml (58238 229 02)


Structured Label Content

Warnings



Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Cough suppressant

Expectorant

Directions
  • For children under 6 years of age, use enclosed dropper
  • do not use enclosed dropper for any other drug product

Children 2 to under 6 years of age:

2.5 mL every 4 hours not to exceed 15 mL in 24 hours, or as directed by a doctor

Children under 2 years of age:

Consult a doctor.

Other Information (Other information)
  • Store at room temperature 15°C-30°C (59°F-86°F)

Inactive Ingredients (Inactive ingredients)

cherry flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose

Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Do Not Use (Do not use)



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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than 1 week, tends to recur, 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.

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • persistent or chronic cough such as occurs with asthma
  • cough accompanied by excessive phlegm (mucus)

Active Ingredients (in Each 5 Ml Teaspoonful) (Active ingredients (in each 5 mL teaspoonful))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor (TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor)



Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor 2oz/60ml (58238 229 02) (TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor 2oz/60ml (58238-229-02))


Advanced Ingredient Data


Raw Label Data

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