Label: COLD AND FLU PLUS CONGESTION DAYTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 79903-190-12
- Packager: WALMART INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 15, 2023
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 30 mL)
- Purpose
-
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- promotes nasal and/or sinus drainage
- temporarily relieves 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:
- 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.
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
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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
equate™
79903-190-12
Compare to
Vicks® DayQuil®
VapoCOOL® Severe
Cold & Flu + Congestion
active ingredients*DAYTIME
SEVERE
VAPOR CHILLINGCold & Flu
+ Congestion• Acetaminophen -
Pain Reliever/Fever Reducer• Dextromethorphan HBr -
Cough Suppressant• Guaifenesin - Exectorant
•Phenylephrine HCl -
Nasal Deongestant
Relieves:•Headache, fever, sore throat, minor aches & pains
•Chest congestion, cough
•Nasal congestion, sinus pressure
•Thins & loosens mucus
For Ages 12+
12 FL OZ (355 mL)
F-059
ORGDISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by The Procter & Gamble Company,
owner of the registered trademark Vicks® DayQuil® VapoCOOL® SEVERE COLD &
FLU + CONGESTIONPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgSatisfaction guaranteed - Or we'll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.
Equate 44-059
-
INGREDIENTS AND APPEARANCE
COLD AND FLU PLUS CONGESTION DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color green (bluish) Score Shape Size Flavor MINT (eucalyptus) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-190-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/15/2023 Labeler - WALMART INC. (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(79903-190) , pack(79903-190)