Label: SEVERE CONGESTION AND COUGH MAX- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 76281-517-25
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 31, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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.
• For children under 12 years of ageAsk a doctor before use if you have ● heart disease ● thyroid disease ● high blood pressure ● diabetes
● trouble urinating due to an enlarged prostate gland ● cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis or emphysema ● cough that occurs with too much phlegm (mucus)When using this product ● do not use more than directed
Stop use and ask a doctor if
●nervousness, dizziness or sleeplessness occur ● symptoms do not get better within 7 days or are accompanied by a
fever ● cough comes back, or occurs with 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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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Maximum Strength Max Severe Congestion & Cough
AP SAFE® NDC 76281-517-25
Compare to Mucinex® FAST-MAX™ Severe Congestion
& Cough Active ingredients*Maximum Strength
Max Severe Congestion & CoughDextromethorphan HBr/
Cough Suppressant
Guaifenesin /Expectorant
Phenylephrine HCI / Nasal DecongestantCongestion& Cough
Relief of:
• Cough
• Thins & Loosens Mucus
• Nasal & Chest CongestionAdults- For Ages 12 and over
6 FL OZ ( 177 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe
Congestion & Cough.res
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INGREDIENTS AND APPEARANCE
SEVERE CONGESTION AND COUGH MAX
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-517 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-517-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/30/2024 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-517)