Severe Sinus Congestion and Pain

Wal-Mart Stores Inc

Equate 44-527C

FULL PRESCRIBING INFORMATION: CONTENTS*

• Purpose
• Severe Sinus Congestion and Pain Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Severe Sinus Congestion and Pain Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever

Expectorant

Nasal decongestant

Severe Sinus Congestion and Pain Uses

• for the temporary relief of:
• headache
• sinus congestion and pressure
• nasal congestion
• minor aches and pain
• helps loosen phlegm (mucus) and thin bronchial secretons to make coughs more productive
• temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies

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

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 englarged 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 have

• 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
• fever gets worse of lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts
• new symptoms occur

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 of 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

Severe Sinus Congestion and Pain Other information

• store at controlled room temperature 15º - 30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

NDC 49035-527-08

equate®

Compare Tylenol® Sinus Congestion & Pain Severe Active Ingredients*

Severe
Sinus Congestion
& Pain
Pain Reliever, Nasal Decongestant, Expectorant

Daytime Non-Drowsy

• Headache - Acetaminophen
• Sinus pressure, nasal congestion - Phenylephrine HCl
• Chest congestion - Guaifenesin

Cool Blast Flavor

24
CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Severe Daytime Caplets .

50844        REV0820E52708

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