FDA Label for Sinus Headache Pe Non- Drowsy Maximum Strength

Active Ingredients (In Each Caplet)

Acetaminophen 325mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Uses

temporarily relieves:

■ nasal and sinus congestion 
■ minor aches and pains
■ headaches

Warnings

Liver warning: ​This product contains acetaminophen. Severe liver damage may occur if you take   ■ more than 8 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.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include   ■ skin reddening   ■ blisters   ■ rash
If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

■ 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  ■ with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have

■ liver disease   ■ heart disease   ■ high blood pressure   ■ thyroid disease   ■ diabetes   ■ trouble urinating due to an enlarged prostate 

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin. 

When Using This Product

 do not use more than directed.

Stop Use And Ask A Doctor If

■ redness or swelling is present   ■ new symptoms occur   ■ you get nervous, dizzy or sleepless   ■ pain gets worse or lasts more than 7 days   ■ fever gets worse or lasts more than 3 days   ■ You may report side effects to 1-888-952-0050

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

■ Adults and children 12 years of age and older: take 2 tablets every 4-6 hours
■ Do not take more than 8 tablets in 24 hours

■ Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems

Other Information

store at room temperature in a dry place

Inactive Ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Package/Label Principal Display Panel

 Compare to the active ingredient in Sudafed PE® PRESSURE + PAIN

CareOne®

See new warnings information

MAXIMUM STRENGTH   NON DROWSY

SINUS HEADACHE PE
Acetaminophen and Phenylephrine HCl

PAIN RELIEVER, NASAL DECONGESTANT
Sinus Pain & Headache
Sinus Pressure
Nasal & Sinus Congestion

Does not contain pseudoephedrine

See New Formula

12 DOSES
2 Pills/Dose

24
COATED CAPLETS*
*Capsule shaped tablets

TAMPER EVIDENT: DO NOT USE IF BLISTER IS TORN

DISTRIBUTED BY: AMERICAN SALES COMPANY
4201 WALDEN AVENUE, LANCASTER, NY 14086
www.care1.info
©2014 S&S Brands, Inc

LB0604
R1115

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.