Label: NON DROWSY NIGHTTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
- NDC Code(s): 30142-787-48
- Packager: 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 March 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 softgels 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
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, 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 sleep
Ask 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
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Directions
- take only as directed - see Overdose warning
- do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use - Other information
- Inactive ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 325 mg Capsule Blister Pack Carton
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INGREDIENTS AND APPEARANCE
NON DROWSY NIGHTTIME COLD AND FLU SOFTGEL
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-787 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 6.5 mg Inactive Ingredients Ingredient Name Strength 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code 787 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-787-48 4 in 1 CARTON 05/01/2021 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 05/01/2021 Labeler - KROGER COMPANY (006999528)