Label: DAYTIME COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid
- NDC Code(s): 30142-722-12
- Packager: The Kroger Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 24, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
- Purposes
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Uses
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- temporarily relieves common cold/flu symptoms:
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- nasal congestion
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- sinus congestion & pressure
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- cough due to minor throat and bronchial irritation
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- minor aches and pains
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- headache
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- fever
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- sore throat
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- reduce swelling of nasal passages
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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- help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 4 doses in 24 hrs which is maximum daily amount for this product
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- taken with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- Skin reddening
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- Blisters
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- 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
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- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
Stop use and ask a doctor if
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- you get nervous, dizzy, or sleepless
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- pain, nasal congestion or cough gets worse, or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
COMPARE TO the active ingredients in VICKS® DAYQUIL™ SEVERE+ VapoCOOL™ *see back panel
NDC 30142-722-12
Daytime
SEVERE COOLING
COLD & FLU RELIEF
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCI - Nasal decongestant
Guaifenesin - Expectorant
FOR RELIEVES OF
Minor Aches & Pains, Fever
Nasal congestion & Sinus Pressure
Cough
Chest congestion
12 FL OZ (354 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
DISTRIBUTED BY THE KROGER CO.
CINCINNATI,OHIO 45202
QUALITY GUARANTEE
800-632-6900
Vicks® Dayquil™ Severe+ VapoCOOL™ are registered trademarks of Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with the Kroger Co. or this product.
- Product Label
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF
acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-722 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) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-722-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/28/2020 Labeler - The Kroger Co. (006999528)