ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE by

Drug Labeling and Warnings

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE by is a Otc medication manufactured, distributed, or labeled by J.P. BUSINESS ENTERPRISE, MEDGEL PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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

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

• 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

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

Questions or comments?

1-888-333-9792

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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

• 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 filled

Product 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)
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
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	12/01/2014
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)