MAXIMUM STRENGTH TUSSIN DM LIQUID FILLED SOFTGELS- dextromethorphan hbr, guaifenesin capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients 
(per Softgel)
Dextromethorphan HBr ....10 mg 
Guaifenesin ..................200 mg 

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

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.

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.

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.

PREGNANCY 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.

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

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.

res

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH TUSSIN DM LIQUID FILLED SOFTGELS 
dextromethorphan hbr, guaifenesin capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	601
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-601-02	2 in 1 CARTON	01/01/2026
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2026

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-601)