Label: NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr and doxylamine succinate capsule
- NDC Code(s): 68016-878-16, 68016-878-24
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
-
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 product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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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 sleep
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
adults & children 12 yrs & over
2 capsules with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 Cpsules Bottle
NDC 68016-878-16
Premier Value®
COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® NYQUIL® COLD & FLU
NIGHTTIME RELIEF LIQUICAPS®Multi-Symptom
Nighttime
COLD & FLU RELIEFAcetaminophen, Dextromethorphan HBr and
Doxylamine Succinate Capsules
325 mg/15 mg/6.25 mg
- Aches, Fever & Sore Throat
- Sneezing, Runny Nose
- Cough
16 Capsules
-
INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr and doxylamine succinate capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-878 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) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code Q07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-878-16 8 in 1 CARTON 07/12/2019 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:68016-878-24 12 in 1 CARTON 07/12/2019 2 2 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 Drug M012 07/12/2019 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 MANUFACTURE(68016-878)