DrugCite

NON-ASPIRIN SINUS CONGESTION AND PAIN - acetaminophen tablet 
FRED'S, INC.

Freds 44-466C

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Uses

  • for the temporary relief of:

    • headache

    • sinus congestion and pressure

    • minor aches and pains

    • nasal congestion

  • helps decongest sinus openings and passages

  • promotes sinus drainage

  • helps clear nasal passages

Warnings

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

  • more than 12 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

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.

Ask a doctor before use if you have

  • liver disease

  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

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

  • 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

  • do not take more than directed (see overdose warning)

  • 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 12 caplets in 24 hours

  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store at controlled room temperature 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

Principal Display Panel

FRED'S®

See New Warnings Information

Non-Aspirin
Sinus
Congestion & Pain
Pain Reliever/Nasal Decongestant

Non-Drowsy
Headache - Acetaminophen
Sinus Pressure
Nasal Congestion - Phenylephrine HCl

Pseudoephedrine Free

24 Cool Caplets
with Cool Blast Flavor

Tested Against The Active Ingredients in: TYLENOL® CONGESTION & PAIN DAYTIME*

Daytime

TAMPER EVIDENT: DO NOT USE IF CARTON 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® Congestion & Pain Daytime.
50844      REV0310C46608

Fred's 44-466C

Fred's 44-466C


NON-ASPIRIN SINUS CONGESTION AND PAIN 
acetaminophen and phenylephrine hcl  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55315-466
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POVIDONES  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
SUCRALOSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 17mm
Flavor MENTHOL Imprint Code 44;466
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55315-466-08 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 24 TABLET In 1 BLISTER PACK This package is contained within the CARTON (55315-466-08)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 07/26/2005

Labeler - FRED'S, INC. (005866116)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Revised: 11/2012FRED'S, INC.