Label: COLD, FLU AND SORE THROAT MAXIUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 53942-516-25
- Packager: DeMoulas Market Basket
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive ingredients (in each 20 mL)
- Purpose
- Keep out of reach of children
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Sever liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
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Do not use
- with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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 age
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
- If pregnant or breast feeding
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- Questions?
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Cold , Flu & Sore Throat product label
"MORE FOR YOUR DOLLAR"
MARKET BASKET
*COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROATCold, Flu and Sore Throat
Maximum Strength
Acetaminophen
Pain Reliever/Fever ReducerDextromethorophan HBr
Cough SuppressentGuaifenesin Expectorant
Phenylephrine HCL
Nasal DecongestantRelieves Fever and Body Aches
Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion6 FL OZ (177mL)
Adults
For Ages 12 and Over*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.
Peel Corner to Read Complete Drug Facts and InformationDO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in consequences
DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
Tewksbury, MA 01876LB-008 Rev 01
Lot:
Exp:res
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INGREDIENTS AND APPEARANCE
COLD, FLU AND SORE THROAT MAXIUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-516 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL 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 HYDROCHLORIDE 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-516-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/19/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/19/2013 Labeler - DeMoulas Market Basket (007869647) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(53942-516)