34759c0f-8885-4ecd-9379-0cd88bf152a8 — v1

2 Views

Version

v1

Effective date

June 30, 2009

Original packager

Sections captured

17

Identifiers

Document ID
22703ed4-6d7f-4caa-9bac-399719e8e447
Set ID
34759c0f-8885-4ecd-9379-0cd88bf152a8
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg
Ask Doctor (1)

Sequence 1

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
Do Not Use (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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
Dosage And Administration Table (1)

Sequence 1

age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

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)
Package Label Principal Display Panel (1)

Sequence 1

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 image of package label
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Cough suppressant Expectorant Nasal decongestant
Questions (1)

Sequence 1

Questions or comments? 1-800-719-9260 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK 74146
Spl Product Data Elements (1)

Sequence 1

Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information each teaspoon contains: sodium 3 mg store at 20º-25ºC (68º-77ºF)
Warnings (1)

Sequence 1

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 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 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)
When Using (1)

Sequence 1

When using this product do not use more than directed