Label: DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 11822-0710-1
- Packager: Rite Aid Corporation
- 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 July 29, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 15 mL)
- Purpose
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Uses
temporarily relieves common cold/flu symptoms:
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- nasal congestion
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- sinus congestion and 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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- reduces 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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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 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 nonprescription). 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- thyroid disease
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- diabetes
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- high blood pressure
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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, chronic bronchitis, or emphysema
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 5 days (children) or 7 days (adults)
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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 rash or headache that lasts. These could be signs of a serious condition.
- Keep out of reach of children.
- Directions
- Inactive ingredients
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Package/Label Principal Display Panel
Compare to the active ingredients of Vicks® DayQuil® Severe
FREE FROM
GLUTEN FREE
ALCOHOL FREE
MAXIMUM STRENGTH
SEVERE COLD & FLU RELIEF
DAYTIME
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
GUAIFENESIN
PHENYLEPHRINE HCl
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
EXPECTORANT
NASAL DECONGESTANT
NON-DROWSY
12 FL OZ (355 mL)
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INGREDIENTS AND APPEARANCE
DAYTIME SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0710 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE (clear) Score Shape Size Flavor FRUIT, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0710-1 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/18/2014 Labeler - Rite Aid Corporation (014578892)
