Label: KROGER NIGHTTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
- NDC Code(s): 30142-086-48
- Packager: The Kroger Company
- 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 July 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each Softgel)
- Purposes
- Uses:
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Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rashIf a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, see 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. • to make a child sleepAsk a doctor before use if you have • liver disease • glaucoma • 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 emphysema • trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
When 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, & tranquilizers may increase drowsiness
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.
If pregnant or breast-feeding, ask a health professional before use.
- Directions:
- Other information:
- Inactive ingredients:
- Questions or comments:
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SPL UNCLASSIFIED SECTION
COMPARE TO the active ingredients of VICKS® NYQUIL®
COLD & FLU NIGHTTIME RELIEF LIQUICAPS® *See bottom panel
POWERFUL NIGHTTIME RELIEF
OUR PHARMACIST RECOMMENDED
Multi-Symptom Relief
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN OR SHOWS ANY SIGN OF TAMPERING
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY
THE KROGER CO.,
CINCINNATI, OHIO 45202MADE IN UAE
For More Product Information, Scan UPC
Using Your Kroger App or Call 800-632-6900
*This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Proctor & Gamble Company.
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- Packaging
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INGREDIENTS AND APPEARANCE
KROGER NIGHTTIME COLD AND FLU SOFTGEL
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-086 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color green Score no score Shape OVAL Size 21mm Flavor Imprint Code 808 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-086-48 4 in 1 CARTON 08/31/2022 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 08/31/2022 Labeler - The Kroger Company (006999528)