NDC | 59105-005-10 |
Set ID | 1d600327-95c1-4512-b32a-430f619df1ac |
Category | HUMAN OTC DRUG LABEL |
Packager | J.P. BUSINESS ENTERPRISE |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan Hydrobromide 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine - Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose and sneezing
- 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
Sore throat warning
If sore throat is severe, lasts for more than 2 days, or 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.
- 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 with 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
Overdose warning
Taking more than the recommended dose 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 as well as for children, even if you do not notice any signs or symptoms.
- Directions
- Take only as recommended—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 every 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
Close - Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine
- Inactive ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Close - Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton
VALUMEDS
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
in VICKS® NyQUIL®*MULTI-SYMPTOM
NITE TIMECOLD & FLU NIGHTTIME RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Antihistamine
10 SOFTGELS
Liquid filled capsules - INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59105-005 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONES (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code 215 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59105-005-10 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(59105-005)