Trispec Dmx Cough Suppressant Expectorant Peach Flavor

Trispec Dmx Cough Suppressant Expectorant Peach Flavor
SPL v6
SPL
SPL Set ID eee53314-655c-496b-bc01-1caa70cbf2b7
Route
ORAL
Published
Effective Date 2016-03-10
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 Propylene Glycol Water Sorbitol Sucralose Maltitol Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-18

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 187 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant



Expectorant

Dosage and Administration

Directions

  • use only with enclosed measuring cup
    • do not use enclosed measuring cup for any other drug product

      Adults and children

      12 years of age

      and older:

      2 teaspoonfuls (tsp) every 4 hours

      not to exceed 8 teaspoonfuls in

      24 hours, or as directed by a doctor.

      Children 6 to under

      12 years of age:

      1 teaspoonful (tsp) every 4 hours

      not to exceed 4 teaspoonfuls in

      24 hours, or as directed by a doctor.

      Children 2 to under

      6 years of age:

      ½ teaspoonful (tsp) every 4 hours

      not to exceed 2 teaspoonfuls in

      24 hours, or as directed by a doctor.

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 187 mg

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

Section 44425-7

Other Information

  • Store at room temperature 15ºC-30ºC (59ºF-86ºF)
Section 50565-1

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

Section 50569-3

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by excessive phlegm (mucus)
Section 51727-6

Inactive Ingredients

Bitter Mask, Citric Acid, Maltitol, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose

Section 53413-1

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

Section 53414-9

If pregnant or breastfeeding ask a health professional before use.

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.

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.

Active Ingredients (in Each 5 Ml Teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Trispec Dmx Cough Suppressant Expectorant Peach Flavor



Trispec Dmx Cough Suppressant Expectorant Peach Flavor 4 Oz/118 Ml (58238 227 04)


Structured Label Content

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

Dosage and Administration (34068-7)

Directions

  • use only with enclosed measuring cup
    • do not use enclosed measuring cup for any other drug product

      Adults and children

      12 years of age

      and older:

      2 teaspoonfuls (tsp) every 4 hours

      not to exceed 8 teaspoonfuls in

      24 hours, or as directed by a doctor.

      Children 6 to under

      12 years of age:

      1 teaspoonful (tsp) every 4 hours

      not to exceed 4 teaspoonfuls in

      24 hours, or as directed by a doctor.

      Children 2 to under

      6 years of age:

      ½ teaspoonful (tsp) every 4 hours

      not to exceed 2 teaspoonfuls in

      24 hours, or as directed by a doctor.

Section 44425-7 (44425-7)

Other Information

  • Store at room temperature 15ºC-30ºC (59ºF-86ºF)
Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by excessive phlegm (mucus)
Section 51727-6 (51727-6)

Inactive Ingredients

Bitter Mask, Citric Acid, Maltitol, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use.

Purpose

Cough suppressant



Expectorant

Warnings



Do Not Use If (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.

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.

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 Cough Suppressant Expectorant Peach Flavor (TRISPEC DMX Cough Suppressant Expectorant Peach Flavor)



Trispec Dmx Cough Suppressant Expectorant Peach Flavor 4 Oz/118 Ml (58238 227 04) (TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 4 OZ/118 ML (58238-227-04))


Advanced Ingredient Data


Raw Label Data

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