Label: DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine capsule, gelatin coated
- NDC Code(s): 80513-301-50
- Packager: Advanced Rx LLC
- 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 May 25, 2023
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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, 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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or last 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.
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- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80513-301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code IS1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80513-301-50 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 final part341 04/24/2023 Labeler - Advanced Rx LLC (042795108)