SINUS HEADACHE PE MAXIMUM STRENGTH- acetaminophen and phenylephrine hydrochloride tablet 
Better Living Brands, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Safeway 44-502_Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant 

Uses

Warnings

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

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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients 

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 gland

Ask a doctor or pharmacist before use if

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 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

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 or symptoms.

Directions

Other information

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid

Principal Display Panel

NDC 21130-766-21

Compare to Sudafed PE® Pressure + Pain active ingredients*

Maximum Strength
Sinus Headache PE
Acetaminophen 325 mg,
•Helps Prevent Nausea and Dizziness Due to Motion Sickness

24 TABLETS

SAFEWAY™

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.             50844     REV1012F40327

DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009

QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com

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

Safeway 44-502

Safeway 44-502

SINUS HEADACHE PE  MAXIMUM STRENGTH
acetaminophen and phenylephrine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-766
Route of Administration ORAL DEA Schedule     
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 44;502
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-766-08 2 in 1 CARTON
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 06/23/2005 06/23/2018
Labeler - Better Living Brands, LLC (009137209)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(21130-766)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(21130-766)

Revised: 7/2015
Document Id: 8c6f2602-df1e-47c7-af39-e19c6934d076
Set id: 2e983d56-9f63-48bc-9f04-a056fce962e6
Version: 5
Effective Time: 20150715
 
Better Living Brands, LLC