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Acetaminophen,Dextromethorphan,Doxylamine

Medically reviewed on December 4, 2016

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Agile Pharmachem
NDC Code: 58805-003

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.

Acetaminophen, Dextromethorphan and Doxylamine Night time Cold and Flu

Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

pain reliever

Cough Suppressant

Antihistamine

Uses

pain reliever, cough suppressant and Antihistamine

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

do not use:

  • with any other drug containing acetaminophen (prescription or not 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.

Ask a doctor before use if you have

  • liver disease
  • Heart disease
  • Thyroid disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland

ask your 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:

  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever

Keep out of reach of children.

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Direction
  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use

Other Information
  • store at room temperature

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 58805-003-14  and 58805-003-04

ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE 
acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
POLYETHYLENE GLYCOL 1000 
POVIDONE 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
GLYCERIN 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code215
Contains    
Packaging
#Item CodePackage Description
1NDC:58805-003-147680 CARTON in 1 BLISTER PACK
11 CAPSULE, LIQUID FILLED in 1 CARTON
2NDC:58805-003-04180 CARTON in 1 BLISTER PACK
21 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2014
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

 
Agile Pharmachem

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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