Alka-Seltzer Plus (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each capsule)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg	Cough suppressant
Phenylephrine hydrochloride 5 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • nasal and sinus congestion
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 10 capsules in 24 hours, which is the maximum daily amount for this product
• 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.
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough with excessive phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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.
• nervousness, dizziness, or sleeplessness occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor
• children under 12 years: do not use

Other Information

• store at room temperature. Avoid excessive heat.

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Distributed by: Bayer HealthCare LLC P.O. Box 1910 Morristown, NJ 07962-1910

Principal Display Panel - 20 Capsule Blister Pack Carton

NEW DIRECTIONS NEW LOOK

Alka- Seltzer PLUS ^®

Acetaminophen / Pain reliever- fever reducer • Dextromethorphan hydrobromide / Cough suppressant • Phenylephrine HCl / Nasal decongestant

DAY NON-DROWSY COLD & FLU FORMULA

Nasal Congestion • Headache & Body Ache Cough • Sore Throat • Sinus Pressure

20 LIQUID GELS (Liquid Filled Capsules)