Label: NIGHTTIME COLD AND FLU- acetaminophen, doxylamine succinate, dextromethorphan hbr capsule, liquid filled
- NDC Code(s): 71679-102-00, 71679-102-50
- Packager: Health Pharma USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2025
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- Official Label (Printer Friendly)
- Active ingredients (in each Softgels)
- Purpose
- 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 hours, 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, 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
- 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
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and 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.
- SPL UNCLASSIFIED SECTION
- Keep out of reach of children
- Direction
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU
acetaminophen, doxylamine succinate, dextromethorphan hbr capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-102 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color green Score no score Shape CAPSULE Size 21mm Flavor Imprint Code CF02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71679-102-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 12/20/2024 12/20/2024 2 NDC:71679-102-00 2 in 1 BOX 01/07/2025 2 1500 in 1 BAG; 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 12/20/2024 Labeler - Health Pharma USA LLC (080804485) Registrant - Health Pharma USA LLC (080804485) Establishment Name Address ID/FEI Business Operations OCEAN HEALTHCARE PVT. LTD. 873673519 manufacture(71679-102)