Label: EQUALINE DAYTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
- NDC Code(s): 41163-656-34, 41163-656-38, 41163-656-40
- Packager: United Natural Foods, Inc. dba UNFI
- 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 1, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 15 mL)
- Purpose
- Uses
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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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- diabetes
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- high blood pressure
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- heart disease
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- thyroid disease
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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
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.
- Directions
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel
compare to Vicks® DayQuil® Cold & Flu active ingredients
EQUALINE®
daytime cold & flu relief
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
phenylephrine HCl (nasal decongestant)
powerful non-drowsy relief
multi-symptom
relieves:
• aches, fever & sore throat
• nasal congestion
• coughs
original flavor
ALCOHOL FREE • ANTIHISTAMINE FREE
12 FL OZ (355mL)
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INGREDIENTS AND APPEARANCE
EQUALINE DAYTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-656 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 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) 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) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Product Characteristics Color ORANGE (clear) Score Shape Size Flavor MENTHOL (with fruit) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-656-38 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/12/2011 10/12/2011 2 NDC:41163-656-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/11/2012 3 NDC:41163-656-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/28/2014 10/17/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/12/2011 Labeler - United Natural Foods, Inc. dba UNFI (943556183)