ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE capsule, liquid filled

Acetaminophen,Dextromethorphan,Phenylephrine by

Drug Labeling and Warnings

Acetaminophen,Dextromethorphan,Phenylephrine by is a Otc medication manufactured, distributed, or labeled by Agile Pharmachem. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

pain reliever

Cough Suppressant

Nasal decongestant

Uses

pain reliever, cough suppressant and Nasal decongestant

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: 58805-002-14  , 58805-002-08

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN,DEXTROMETHORPHAN,PHENYLEPHRINE 
acetaminophen,dextromethorphan,phenylephrine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58805-002
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	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	512
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58805-002-14	7680 in 1 BLISTER PACK
1		1 in 1 CARTON
2	NDC: 58805-002-08	8 in 1 BLISTER PACK
2		180 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2014

Labeler - Agile Pharmachem (650687853)

Registrant - Agile Pharmachem (650687853)