Label: EQUATE VAPOR ICE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 49035-708-62
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 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 caplet)
- Purpose
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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 and pressure
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- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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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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- runny nose and sneezing
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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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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- 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.
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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
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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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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- trouble urinating due to an enlarged prostate gland
- Ask a doctor or pharmacist before use if you are
- When using this product
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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 rash or headache that lasts. These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
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Inactive ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
- Questions or comments?
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Package/Label Principal Display Panel
Compare to Vicks® NyQuil® Severe+ VapoCOOL™ active ingredients
SEVERE+
NIGHTTIME
VAPOR ICE™ Cold & Flu
Acetaminophen – Pain Reliever/Fever Reducer
Phenylephrine HCl – Nasal Decongestant
Doxylamine Succinate – Antihistamine
Dextromethorphan HBr – Cough Suppressant
Relief of:
Minor aches & pains, fever
Nasal congestion & sinus pressure
Sneezing, runny nose
Cough
Alcohol-Free
Actual Size
24 CAPLETS
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INGREDIENTS AND APPEARANCE
EQUATE VAPOR ICE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-708 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 19mm Flavor Imprint Code L72V Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-708-62 12 in 1 CARTON 07/14/2020 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/14/2020 Labeler - Wal-Mart Stores Inc (051957769)
