Label: VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
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- NDC Code(s): 37000-555-08, 37000-555-12, 37000-555-24
- Packager: The Procter & Gamble Manufacturing Company
- 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 September 12, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Active ingredients (in each 15 mL tablespoon) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant - Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if adult/child takes
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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.
CloseOverdose warning
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
- Directions
- take only as directed - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL (2 TBSP) every 4 hrs children 6 to under 12 yrs 15 mL (1 TBSP) every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use - when using other DayQuil or NyQuil® products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
carboxymethylcellulose sodium, citric acid, disodium EDTA, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
50% MORE
than our 8 oz sizeVICKS®
DayQuil®
COLD & FLU
Multi-Symptom Relief
Acetaminophen, Phenylephrine, Dextromethorphan
- Aches, Fever & Sore Throat
- Nasal Congestion
- Cough
Non-Drowsy
Alcohol Free / Antihistamine Free12 FL OZ
(354 ml)Close
- INGREDIENTS AND APPEARANCE
VICKS DAYQUIL COLD AND FLU MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-555 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 carboxymethylcellulose sodium (UNII: K679OBS311) citric acid monohydrate (UNII: 2968PHW8QP) edetate disodium (UNII: 7FLD91C86K) FD&C Yellow No. 6 (UNII: H77VEI93A8) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) saccharin sodium (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sodium chloride (UNII: 451W47IQ8X) sodium citrate (UNII: 1Q73Q2JULR) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score Shape Size Flavor APRICOT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-555-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:37000-555-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:37000-555-24 2 in 1 PACKAGE, COMBINATION 3 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/22/2011 CloseLabeler - The Procter & Gamble Manufacturing Company (004238200)