Otc - Active Ingredient
Drug Facts
Active ingredients
(per Softgel)
Dextromethorphan HBr ....10 mg
Guaifenesin ..................200 mg
Maximum Strength Tussin Dm Liquid Filled Softgels Capsule, Liquid Filled
FDA Label NDC 76281-601
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 Maximum Strength Tussin Dm Liquid Filled Softgels (NDC 76281-601). 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 - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Dextromethorphan HBr ....Cough Suppressant
Guaifenesin ....................Expectorant
Indications & Usage
Uses
• helps loosen phlegm (mucus) and thin bronchial
secretions to make cough more productive
• temporarily relieves cough due to minor throat
and bronchial irritation as may occur with a cold
Warnings
Warnings
Otc - 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 two 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.
Otc - Ask Doctor
Ask a doctor before use if you have
• 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 - Stop Use
Stop use and ask a doctor if
• cough lasts for more than 7 days, comes back, or is accompanied by
fever, rash or persistent headache. These couid be
signs of a serious 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 a
Poison Control Center right away.
Dosage & Administration
Directions
• do not take more than 12 softgels in any 24-hour period
• This product is not intended for use in children under 12 years
• Adults & children 12 years and over - 2 softgels every 4 hours
• Children under 12 years of age - do not use
Other Safety Information
Other information
• Store at room temperature
• Avoid excessive heat above 40°C (104°F)
Inactive Ingredient
Inactive ingredients
FD&C Red #40, Gelatin, glycerin, Polyethylene glycol, Povidone, Propylene glycol, purified water,
Sorbitol sorbitan solution, Titanium dioxide
Otc - Questions
Questions?1-877-798-5944
Product Label: Ap Safe Chest Congestion & Cough Relief Dm
------------------------------------------------------
AP SAFE® Chest Congestion *Compare to the active ingredients
& Cough Relief DM In Robitussin®Maximum Strength
Cough & Chest Congestion DM
Dextromethorphan HBr - Cough suppressant
Guaifenesin - Expectorant
Ages 12+
20 Softgels
Manufactured by AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110
• This product is not manufactured or distributed by Pfizer Consumer Healthcare,
distributors of Robitussin® Maximum Strength Cough & Chest Congestion DM
TAMPER EVIDENT:DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
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* Please review the disclaimer below.
