SINUS HEADACHE PE NON- DROWSY MAXIMUM STRENGTH- acetaminophen and phenylephrine hcl tablet

Sinus Headache PE Non- Drowsy by

Drug Labeling and Warnings

Sinus Headache PE Non- Drowsy by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325mg
Phenylephrine HCl 5mg

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
• do not use if blister package is torn

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

CareOne® 

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

SINUS PRESSURE + PAIN PE
Pain Reliever - Acetaminophen 
Nasal Decongestant - Phenylephrine HCl

Max Strength

Relieves:
Sinus Pain & Headache
Sinus Pressure
Nasal & Sinus Congestion

Does not contain pseudoephedrine

NON-DROWSY

24
COATED CAPLETS*
*Capsule - Shaped Tablets

DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785  1-877-846-9949
©2016 S&S Brands, LLC
Quality guaranteed or your money back

LB0604
R0316

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

Care One Sinus Pressure + Pain PE

INGREDIENTS AND APPEARANCE

SINUS HEADACHE PE NON- DROWSY  MAXIMUM STRENGTH
acetaminophen and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-270
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AZ270
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-270-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/12/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/12/2014

Labeler - American Sales Company (809183973)