Label: COLD AND FLU RELIEF MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit
- NDC Code(s): 67091-309-48
- Packager: WinCo Foods, LLC
- 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 October 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients in Daytime (in each softgel)
- Active ingredients in Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
- Uses
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Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- 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
- 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 (Daytime-Nighttime)
- heart disease (Daytime)
- diabetes (Daytime)
- thyroid disease (Daytime)
- high blood pressure (Daytime)
- glaucoma (nighttime)
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, emphysema (Daytime)
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Nighttime)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product,
Daytime: do not use more than directed.
Nighttime:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur (Daytime only)
- pain, cough, and nasal congestion gets worse or lasts more than 7 days (Daytime)
- pain or cough gets worse or lasts more than 3 days (Nighttime)
- 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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see Overdose warning )
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours
- children under 12 years: do not use
- Other information
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Inactive ingredeints for Daytime
butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan, sorbitol
*contains one or more of these ingredients
- Inactive ingredients in Nighttime
- Questions or comments?
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Principal Display Panel
**Compare to the Active Ingredients in VICKS® DAYQUIL® & NyQUIL® LiquiCaps®
Multi-Symptom Cold & Flu Relief
NON-DROWSY
DAYTIME
ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCI / NASAL DECONGESTANT
Relieves: Aches, Fever, Sore Throat, Cough & Nasal Congestion
Nighttime
ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
Relieves: Aches, Fever, Sore Throat, Cough, Sneezing & Runny Nose.
Softgels
**Liquid Filled Capsules
When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
†This product is not manufactured or distributed by THE PROCTER & GAMBLE COMPANY, VICKS®, DAYQUIL®, NYQUIL® AND LiquiCap® are registered trademarks of THE PROCTER & GAMBLE COMPANY.
DISTRIBUTED BY:
WINCO FOODS, LLC
BOISE, ID 83704
- Product Label
-
INGREDIENTS AND APPEARANCE
COLD AND FLU RELIEF MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-309 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-309-48 1 in 1 CARTON; Type 0: Not a Combination Product 09/30/2016 12/31/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 16 Part 2 32 BLISTER PACK 32 Part 1 of 2 COLD AND FLU RELIEF MULTI SYMPTOM NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsuleProduct Information 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 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color green Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P30;94A;215;P120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 in 1 CARTON 1 1 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 final part341 09/30/2016 05/31/2024 Part 2 of 2 COLD AND FLU RELIEF MULTI SYMPTOM NON DROWSY DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsuleProduct Information 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) CARMINIC ACID (UNII: CID8Z8N95N) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SODIUM METABISULFITE (UNII: 4VON5FNS3C) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P19;95A;512;P119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 32 in 1 CARTON 1 1 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 final part341 09/30/2016 05/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/30/2016 12/31/2024 Labeler - WinCo Foods, LLC (056098817)
