MOORE MEDICAL MOOREBRAND SEVERE COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated 
Moore Medical LLC

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.

----------

Moore Medical Severe Cold Relief Label

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

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

Liver warning:

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • if you ever had an allergic reaction to this product or any of its 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)

■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a 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

  • 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.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid.

*May contain

Questions or comments?

Call 1.800.234.1464

Moore Medical Severe Cold Relief Label

moore medical
Supporting Health & Care

Reorder No. 87677
UPN# 0-0607415-87677-2
Moore Brand®
Severe Cold Relief Tablets

Pseudoephedrine-Free
250 Packets/2 Tablets
Each Packet Net Wt. 650 mg

Acetasminophen 325 mg,

Guaifenesin 200 mg,

Dextromethorphan HBr 15 mg,

Phenylephrine HCl 5 mg

This Package is for Households without Young Children.

MM Cold

MOORE MEDICAL MOOREBRAND SEVERE COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55670-143
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code FR;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55670-143-13250 in 1 BOX12/30/200804/28/2023
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/200804/28/2023
Labeler - Moore Medical LLC (051420107)

Revised: 3/2022
 
Moore Medical LLC