Label: NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 63868-468-24
- Packager: Chain Drug Marketing Association, Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 3, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each softgel)
- Purposes
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Uses
• temporarily relieves common cold/flu symptoms:
• nasal congestion • sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep • minor aches & pains
• headache • fever • sore throat
• runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage -
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 softgels in 24 hours, which is the maximum daily amount for this product • 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
• heart disease • high blood pressure • thyroid disease
• diabetes • glaucoma
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysemaAsk a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarinWhen using this product
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsinessStop use and ask a doctor if
• you get nervous, dizzy or sleepless • pain, nasal congestion, 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.If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredients in Vicks® NyQuil™ Severe Cold & Flu Relief LiquiCaps™*
Temporarily relieves common cold/flu symptoms:
aches, fever and sore throat
controls cough
nasal congestion
runny nose and sneezingREAD AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF PACKAGE 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 Company, owner of the registered trademarks Vicks®, NyQuil™.
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www.qualitychoice.com
Questions: 800-935-2362Product of India
Packaged and Quality Assured in the USA - Packaging
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INGREDIENTS AND APPEARANCE
NIGHTTIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-468 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL (oblong) Size 20mm Flavor Imprint Code 789 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-468-24 2 in 1 CARTON 05/03/2022 1 12 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 05/03/2022 Labeler - Chain Drug Marketing Association, Inc. (011920774)