COLD AND FLU RELIEF MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate
WinCo Foods, LLC
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.
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Drug Facts
Active ingredients in Daytime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients in Nighttime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- cough due to minor throat and bronchial irritation
- nasal congestion (Daytime only)
- runny nose and sneezing (Nighttime only)
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
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
- to make a child sleep (Nitetime only)
- 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
- 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, and (for Nighttime only) chronic bronchitis
- glaucoma (Nighttime only)
- diabetes (Daytime only)
- heart disease (Daytime only)
- thyroid disease (Daytime only)
- high blood pressure (Daytime only)
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,
do not use more than directed.
In addition, when using Nighttime:
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- 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 (for Daytime only) nasal congestion gets worse or lasts more than 7 days
- 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.
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
Inactive ingredeints for Daytime
butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
*may contain this ingredient
Inactive ingredients in Nighttime
D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan sorbitol
Principal Display Panel
**Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®
Multi-Symptom Cold & Flu Relief
NON-DROWSY
DAYTIME
Acetaminophen/Pain reliever-fever reducer
Dextromethorphan HBr/cough suppressant
Phenylephrine HCl/Nasal decongestant
Relieves: aches, fever, sore throat, cough and nasal congestion
Nighttime
Acetaminophen/pain reliever-fever reducer
Dextromethorphan HBr/cough suppressant
Doxylamine succinate/antihstamine
Relieves: aches, fever, sore throat, cough, sneezing & runny nose.
Softgels
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 OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
**This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® DayQuil® and NyQuil® LiquiCaps®
DISTRIBUTED BY:
WINCO FOODS, LLC
BOISE, ID 83704
| COLD AND FLU RELIEF
MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit |
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| Labeler - WinCo Foods, LLC (056098817) |