Allergy Plus Sinus Headache

Greenbrier International, Inc.

Assured 44-464

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Allergy Plus Sinus Headache 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
• Allergy Plus Sinus Headache Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Allergy Plus Sinus Headache Uses

• temporarily relieves these symptoms of hay fever and the common cold:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
• temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes

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 acetamminophen
• 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.
• with any other product containing diphenhydramine, even one used on the skin
• 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
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets wrse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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 use more than directed (see overdose warning)
• adults and children 12 years and over
  • take 2 tablets every 4 hours
  • 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

Allergy Plus Sinus Headache Other information

• store at 25ºC (77ºF); excursions permitted between 59º-77ºF in a dry place
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENTS OF BENADRYL® ALLERGY PLUS SINUS HEADACHE*

MULTI-SYMPTOM
ALLERGY
PLUS SINUS HEADACHE

• Acetaminophen - Pain Reliever
• Diphenhydramine HCl - Antihistamine
Phenylephrine HCl - Nasal Decongestant

Headache, Sneezing, Itchy & Watery Eyes, Runny Nose, Itchy Throat, Sinus Congestion & Pressure

24 CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Plus Sinus Headache.
50844        ORG061246408

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