Label: ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE- acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
- NDC Code(s): 59105-004-10
- Packager: J.P. BUSINESS ENTERPRISE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated November 14, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each softgel) Purpose Acetaminophen 325 mg, USP Pain reliever/fever reducer Dextromethorphan Hydrobromide 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
temporarily relieves common cold/flu symptoms:
- minor aches
- sore throat
- muscular aches
- nasal congestion
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
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.
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
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- symptoms get 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
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.
- Take only as directed—see Overdose warning.
- do not exceed 4 doses per 24 hours.
adults and children 12 years of age and over swallow 2 softgels with water children 4 to under 12 years of age ask a doctor children under 4 years of age do not use
If taking Daytime and Nighttime softgels carefully read each label to insure correct dosingClose
- Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine
- Inactive ingredients
FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxideClose
- Questions or comments?
- SPL UNCLASSIFIED SECTION
Distributed By: J.P Business EnterpriseClose
Lake Grove, NY 11755
- PRINCIPAL DISPLAY PANEL - 10 Capsule Blister Pack Carton
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
in VICKS® DAYQUIL®*
COLD & FLU MULTI-SYMPTOM RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHERNE HCl
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Nasal Decongestant
Liquid filled capsules
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, phenylephrine hydrochloride, and dextromethorphan hydrobromide capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59105-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONES (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 20mm Flavor Imprint Code 512 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59105-004-10 1 in 1 CARTON 1 10 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 NOT FINAL part343 12/01/2014 Labeler - J.P. BUSINESS ENTERPRISE (078775890) Establishment Name Address ID/FEI Business Operations MEDGEL PVT LTD 677385498 MANUFACTURE(59105-004)