Label: COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 55319-705-45
- Packager: Family Dollar Services Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 28, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purpose
-
Uses
- temporarily relieves these common cold and flu symptoms:
- headache
- stuffy nose
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- nasal congestion
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily reduces fever
- temporarily relieves these common cold and flu symptoms:
-
Warnings
Liver warning: This product contains acetaminophen. Severe 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 every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- rash
- blisters
- skin reddening
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.
Do not use
- with any other drug 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- diabetes
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- heart disease
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
FAMILY
Wellness™COMPARE TO THE
ACTIVE INGREDIENTS IN
MAXIMUM STRENGTH
MUCINEX® FAST-MAX®
COLD, FLU & SORE THROAT*MAXIMUM STRENGTH
COLD, FLU &
SORE THROATAcetaminophen
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Pain Reliever/Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant• Relieves body pain, headache,
fever & sore throat
• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus
• Relieves sinus pressure & congestionAGES
12 YEARS
& OVERMIXED BERRY
FLAVOREDNDC 55319-705-45
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org*This product is not manufactured or distributed by RB Health (US) LLC, owner
of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold, Flu
& Sore Throat. 50844 ORG052300545DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to
the store of purchase for
a refund (with receipt)
or exchange.
Family Wellness 44-005
-
INGREDIENTS AND APPEARANCE
COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-705 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color blue Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-705-45 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/28/2024 Labeler - Family Dollar Services Inc (024472631) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(55319-705) , pack(55319-705)