COLD MULTI-SYMPTOM - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, film coated 
Stephen L. LaFrance Pharmacy, Inc.

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Select Brand 44-503c

Active ingredient(s)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestion

Use(s)

• temporarily relieves these common cold/flu symptoms:

• headache

• minor aches and pains

• sore throat

• nasal congestion

• 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

• diabetes

• heart disease

• high blood pressure

• thyroid disease

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough 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 exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain, nasal congestion, or cough gets worse or lasts more than 7 days

• new symptoms occur

• fever gets worse or lasts more than 3 days

• redness or swelling is present

• 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 (overdose) may cause liver damage. 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

• do not take more than directed (see overdose 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; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake,  flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

select brand®

the lower price name brand

See New Warnings Information

Cold

Multi-Symptom

Pain Reliever/Fever Reducer

Nasal Decongestant, Cough Suppressant

Expectorant

SEVERE

Fever, Headache, Sore Throat - Acetaminophen

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan

Chest Congestion - Guaifenesin

*Compare to the active ingredients of Tylenol® Cold Multi-Symptom Severe

24 COOL CAPLETS

with Cool Blast Flavor

Daytime

Non-Drowsy

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844      REV0410A50308

Distributed by:

SELECT BRAND® DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

COLD MULTI-SYMPTOM  acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin   tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 15127-962 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 CROSPOVIDONE   D&C YELLOW NO. 10   MAGNESIUM STEARATE   MALTODEXTRIN   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYVINYL ALCOHOL   POVIDONE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   SUCRALOSE   TITANIUM DIOXIDE

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 19mm Flavor MENTHOL Imprint Code 44;503 Contains

Packaging # NDC Package Description Multilevel Packaging 1 15127-962-24 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 24 TABLET In 1 BLISTER PACK This package is contained within the CARTON (15127-962-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/22/2006

Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)

Revised: 05/2011Stephen L. LaFrance Pharmacy, Inc.