Cold Head Congestion Severe

Stephen L. LaFrance Pharmacy, Inc.

Select Brand 44-503

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Cold Head Congestion Severe Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Cold Head Congestion Severe Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (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 decongestion

Cold Head Congestion Severe Uses

• temporarily relieves these common cold/flu symptoms:

  • headache

  • minor aches and pains

  • sore throat

  • nasal congestion

  • impulse to cough 

  • 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

Cold Head Congestion Severe Other information

• store at 25ºC (77ºF); excursions permitted between 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

NDC 15127-964-24

select brand®
the lower price name brand

Cold
Head Congestion
Severe 

Pain Reliever/Fever Reducer
Nasal Decongestant, Cough Suppressant
Expectorant

Headache, Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan
Chest Congestion - Guaifenesin

*Compare to the active ingredients of Tylenol® Cold Head Congestion Severe Daytime

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Head Congestion Severe Daytime.
50844      REV0512C50308

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635