Label: NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated
- NDC Code(s): 80513-302-50
- Packager: Advanced Rx LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 13, 2024
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- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
-
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 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 products containing acetaminophen (prescription or non-prescription). 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
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 an 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 exceed recommended dosage
- 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 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.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80513-302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN (UNII: 6O92ICV9RU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code IS2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80513-302-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/24/2023 Labeler - Advanced Rx LLC (042795108)