ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled 
J.P. BUSINESS ENTERPRISE

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.

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ACETAMINOPHEN DEXTROMETHORPHAN HBr & DOXYLAMINE SUCCINATE SOFTGEL CAPSULES

Drug Facts

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

adults and children 12 years of age and overswallow 2 softgels with water every 6 hours
children 4 to under 12 years of ageask a doctor
children under 4 years of agedo not use

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

Other information

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

Questions or comments?

1-888-333-9792

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton

VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients
in VICKS ® NyQUIL ®*

MULTI-SYMPTOM
NITE TIME

COLD & FLU NIGHTTIME RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE

10 SOFTGELS
Liquid filled capsules

Principal Display Panel - 10 Softgel Blister Pack Carton
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59105-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
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
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code 215
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59105-005-101 in 1 CARTON12/01/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/01/2014
Labeler - J.P. BUSINESS ENTERPRISE (078775890)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PVT LTD677385498manufacture(59105-005)

Revised: 12/2019
Document Id: 9aa9482e-0ab4-6444-e053-2995a90ad027
Set id: 1d600327-95c1-4512-b32a-430f619df1ac
Version: 2
Effective Time: 20191226
 
J.P. BUSINESS ENTERPRISE