Tussin Cf Drug Data

Tussin Cf Drug Data
SPL v1
SPL
SPL Set ID 34759c0f-8885-4ecd-9379-0cd88bf152a8
Route
ORAL
Published
Effective Date 2011-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-01-13

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Section 42229-5

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, OK      74146

Directions
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter; tsp = teaspoonful
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years 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.
Other Information
  • each teaspoon contains: sodium 3 mg
  • store at 20º-25ºC (68º-77ºF)
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Non-Drowsy

Tussin CF Cough & Cold

Cough Suppressant

(Dextromethorphan HBr)  Expectorant (Guaifenesin)

Nasal Decongestant

(Phenylephrine HCl)

Relieves:  Coughs /Stuffy Nose /Chest Congestion Mucus

Adult

For Ages 12 & Over

Alcohol Free

Compare to active ingredients of Robitussin® Cough & Cold CF





NDC 54868-6223-1

237 mL

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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.
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)

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredient (in Each 5 Ml Tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Section 42229-5 (42229-5)

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, OK      74146

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter; tsp = teaspoonful
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
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.
Other Information (Other information)
  • each teaspoon contains: sodium 3 mg
  • store at 20º-25ºC (68º-77ºF)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Non-Drowsy

Tussin CF Cough & Cold

Cough Suppressant

(Dextromethorphan HBr)  Expectorant (Guaifenesin)

Nasal Decongestant

(Phenylephrine HCl)

Relieves:  Coughs /Stuffy Nose /Chest Congestion Mucus

Adult

For Ages 12 & Over

Alcohol Free

Compare to active ingredients of Robitussin® Cough & Cold CF





NDC 54868-6223-1

237 mL

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredient (in Each 5 Ml Tsp) (Active ingredient (in each 5 mL tsp))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg


Advanced Ingredient Data


Raw Label Data

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