Non-Drowsy Sinus Congestion and Pain description, usages, side effects, indications, overdosage, supplying and lots more!

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Non-Drowsy Sinus Congestion and Pain

FRED'S, INC.

Freds 44-466C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Non-Drowsy Sinus Congestion and Pain 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

Non-Drowsy Sinus Congestion and Pain Other information

  • store at 25ºC (77ºF); 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

Principal Display Panel

FRED'S®

Daytime
Pseudoephedrine Free

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

24 Cool Caplets
with Cool Blast Flavor

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Congestion & Pain Daytime.
50844      REV0612D46608

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

Non-Drowsy Sinus Congestion and Pain
Fred's 44-466C

Non-Drowsy Sinus Congestion and Pain

Acetaminophen and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-466
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 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 Size Imprint Code Shape
GREEN 17 mm 44;466 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:55315-466-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-07-26


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Be sure to consult your doctor before taking any medication!
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