SINUS AND HEADACHE DAYTIME NON-DROWSY- acetaminophen and phenylephrine hcl tablet, film coated
FRED'S, INC.

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.

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Freds Pharmacy 44-466C-Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- minor aches and pains
- headache
- nasal congestion
- sinus congestion and pressure
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
temporarily reduces fever

Warnings

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

more than 4,000 mg 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:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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.
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
difficulty in urination due to enlargement of the prostate gland
heart disease
diabetes
thyroid disease
high blood pressure

Ask a doctor or pharmacist before use if you are

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
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

fred's
Pharmacy

NDC 55315-532-24

Daytime Non-Drowsy

SINUS &
HEADACHE

Acetaminophen - Pain Reliever/Fever Reducer
Phenylephrine HCl - Nasal Decongestant

• Sinus Headache and Pressure
• Nasal Congestion

24 CAPLETS

Compare to the active ingredients in:
Tylenol® SINUS +
HEADACHE*

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

*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Tylenol®
SINUS + HEADACHE.
50844 ORG031646608

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
guaranteed

Questions or comments: 1-855-331-FRED (3733)

Freds Pharmacy 44-466C

SINUS AND HEADACHE DAYTIME NON-DROWSY
acetaminophen and phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-532
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	44;466
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55315-532-24	2 in 1 CARTON	07/26/2005	02/18/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/26/2005	02/18/2021

Labeler - FRED'S, INC. (005866116)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(55315-532)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(55315-532)

Revised: 1/2021

Document Id: dbb6f5b3-bfc4-4ce6-b44e-607cbaf62f36

Set id: 0e3a7643-68d1-4fbd-9cdc-25ecef2aac0f

Version: 5

Effective Time: 20210126

FRED'S, INC.