COLD RELIEF - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, coated 
Meijer Distribution Inc

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Meijer Distribution, Inc. Cold Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms:
• minor aches and pains
• sore throat
• cough
• headache
• nasal congestion
• impulse to cough
• 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 12 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 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 lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

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

• you get nervous, dizzy or sleepless
• pain, nasal congestion 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see Liver warning)

adults and children 12 years and over	take 2 caplets every 4 hours swallow whole – do not crush, chew or dissolve do not take more than 12 caplets in 24 hours
children under 12 years	do not use this adult product in children under 12 years of age

Other information

• each caplet contains: sodium 3 mg

Inactive ingredients

acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Cold Head Congestion Severe active ingredients

See New Warnings Information

Cool Ice®

Instant Cooling Sensation

Cold Relief

Head Congestion

Severe

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant

Headache / Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Chest Congestion – Guaifenesin

Non-Drowsy

DayTime

COLD RELIEF  acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41250-234 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM   CARNAUBA WAX   CROSCARMELLOSE SODIUM   CROSPOVIDONE   MALTODEXTRIN   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYVINYL ALCOHOL   POVIDONE   SILICON DIOXIDE   STEARIC ACID   TALC   TITANIUM DIOXIDE

Product Characteristics Color YELLOW Score no score Shape OVAL Size 20mm Flavor Imprint Code L234 Contains

Packaging # NDC Package Description Multilevel Packaging 1 41250-234-62 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (41250-234-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/12/2008

Labeler - Meijer Distribution Inc (006959555)

Revised: 12/2009Meijer Distribution Inc