Tussin Cf Liquid
FDA Label NDC 76281-504

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Tussin Cf (NDC 76281-504). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.