FDA Label for Tussin Cf
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRODUCT LABEL
Tussin Cf Product Label
The following document was submitted to the FDA by the labeler of this product Aptapharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg
Otc - Purpose
Purpose
Dextromethorphan HBr USP ........Cough Suppressant
Guailenesin USP ..........................Expectorant
Phenylephrine HCI, USP ...............Nasal Decongestant
Indications & Usage
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.
Warnings
Warnings
Do not use ■ if you are now taking aprescription
monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychialric or emotional conditions or
Parkinson's disease), or for 2 weeks aMer stopping
the MAOI drug. If you do not know il your
prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes
■ trouble urinating due to 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.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use il you are
taking any other oral nasal decongestant or stimulant.
Otc - When Using
When using this product do not use more than
directed.
Otc - Stop Use
Stop use and ask a doctor if
■ you get nervous, diuy 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 ot aserious
condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose,
get medical help or contact aPoison Control Center
right away.
Dosage & Administration
Directions
■ do not take more than 6 doses in any 24 hour period
■ this adult strength product is not intended for use in
children under 12 years of age
AGE | DOSE |
Adults & children 12 years & over | 2 teaspoons every 4 hours |
Children under 12 years | 2 teaspoons every 4 hours |
Other Safety Information
Other information
■ Keep carton for full Direction for use
■ store at 20-25°C (68-77°F)
■ do not refrigerate
■ dosage cup provided
■ sodium 3 mg per teaspoonful
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin,
menthol, natural & artificial flavor, propylene glycol,
purified water, sodium benzoate, sorbitol solution,
sucralose
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877·798-5944
Product Label
AP SAFE NDC 76821-504-24
COMPARE TO THE ACTIVE
INGREDIENT IN ROBITUSSIN®
PEAK COLD
MULTI-SYMPTOM COLD*
Adult Tussin
Multi-Symptom Cold
Dextromethorphan HBr / Guaifensesin /
Phenylephrine HCL
Cough Supressant / Expectorant /
Nasal Decongestant
Non-Drowsy
Relieves:
• Cough
• Mucus
• Nasal Congestion
• For Ages 12 and over
4 FL OZ (118 mL)
CF
DO NOT USE IF PRINTED SEAL UNDER
CAP IS TORN OR MISSING
5
1013430
3/20
*This product is not manufactured or distributed
by Plizer, owner of the registered trademark
Robitussin®
Manufactured by:
AptaPharma Inc.,
1533 Union Ave,
Pennsauken, NJ 08110
Ap·BX·05
Carton
Bottle
res
* Please review the disclaimer below.