Nighttime Cold Flu Relief by CVS Pharmacy / P & L Development, LLC Drug Facts
Nighttime Cold Flu Relief by
Drug Labeling and Warnings
Nighttime Cold Flu Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, P & L Development, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
CVS Pharmacy
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 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
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains 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
- 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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- 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
- pain or cough 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
- adults and children 12 years and over: take 2 softgels with water every 6 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive ingredients
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® NyQuil® LiquiCaps®†
Multi-Symptom
NIGHTTIME COLD/FLU RELIEF
ACETAMINOPHEN...PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr...COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE...ANTIHISTAMINE
Relieves aching, fever, sore throat, coughing, sniffling, & sneezing so you can rest
SOFTGELS
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
www.cvs.com 1-800-shop-CVS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IS BLISTER UNIT IF TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks®, NyQuil®, and LiquiCaps®.
| NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled |
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| Labeler - CVS Pharmacy (062312574) |
| Registrant - P & L Development, LLC (800014821) |