Daytime Nighttime Cold Flu Relief by Safeway, Inc. Drug Facts
Daytime Nighttime Cold Flu Relief by
Drug Labeling and Warnings
Daytime Nighttime Cold Flu Relief by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Safeway, Inc.
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 these products
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 (Nighttime 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 exceed recommended dosage.
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 ingredients in
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
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
Non-Drowsy Daytime Cold & Flu Relief
Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg - Cough Suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant
Compare to Vicks® DayQuil® LiquiCaps® active ingredients†
- Alcohol Free
- Antihistamine Free
Nighttime Cold & Flu Relief
Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Dextromethorphan HBr 15 mg - Cough Suppressant
Doxylamine succinate 6.25 mg - Antihistamine
Compare to Vicks® NyQuil® LiquiCaps® active ingredients†
- Alcohol Free
SOFTGELS Daytime Nighttime
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.
DISTRIBUTED BY SAFEWAY INC.,
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-SAFEWAY / www.safeway.com
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
| DAYTIME NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - Safeway, Inc. (009137209) |