Medique decorel forte plus tablet, film coated

Spl unclassified section

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15mg

Guaifenesin 200mg

Phenylephrine Hydrochloride 5mg

Purposes

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold symptoms

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

Warnings

Spl unclassified section

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

  • more than 8 tablets 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

Spl unclassified section

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult 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.
  • with any other product containing any of the above active ingredients
  • 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

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
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic drinks
  • be careful driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • you get nervous, dizzy or sleepless
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

Keep out of reach of children.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.

Directions

Adults and children: (12 years and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

  • store at room temperature 59-86F (15-30C)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

croscarmellose sodium*, hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone*, sodium starch glycolate*, starch, stearic acid.

*may contain

Questions or comments? 1-800-634-7680

Ingredients and appearance - Product information

Medique decorel forte plus tablet, film coated- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 47682-425
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 15 mgin 1
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color white (white) Shape ROUND (ROUND)
Size 12 mm Score 1
Imprint Code AZ;273

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Medi-first cold relief tablet, film coated- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 47682-822
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 15 mgin 1
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color white (white) Shape ROUND (ROUND)
Size 12 mm Score 1
Imprint Code AZ;273

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Medi-first plus cold relief tablet, film coated- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 47682-922
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 15 mgin 1
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color white (white) Shape ROUND (ROUND)
Size 12 mm Score 1
Imprint Code AZ;273

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Unifirst First Aid Corporation( 832947092)

425r medique decorel forte plus label

Medique®

Decorel Forte Plus

See new warnings information

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Pull to Open

Easy To Swallow

Film Coated Tablets

100 Tablets

(50 x 2)

Severe Cold and Cough Relief

Tamper Evident Unit Dose Packets

425r mf cold relief label

100 Tablets

(50 x 2)

Medi-First®

Cold Relief Multi-Symptom

Acetaminophen 325mg

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Pull to Open

Easy To Swallow

Film Coated Tablets

See new warnings information

Tamper Evident Unit Dose Packets

425r mfp cold relief label

100 Tablets

(50 x 2's)

Medi-First® Plus

Cold Relief

Multi-Symptom

Acetaminophen 325mg

Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Pull to Open

Easy To Swallow

Film Coated Tablets

See new warnings information

Tamper Evident Unit Dose Packets