Maximum Strength Sinus Headache description, usages, side effects, indications, overdosage, supplying and lots more!

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Maximum Strength Sinus Headache

Dolgencorp, LLC

Dollar General 44-502


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant 

Maximum Strength Sinus Headache Uses

  • temporarily relieves headache, minor aches and pains
  • temporarily relieves nasal congestion 

Warnings

 Liver warning: This product containsa 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 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

  • do not use more than directed (see overdose warning)
  • adults and children 12 ears and over
    • take 2 caplets every 4 hours
    • 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. 

Maximum Strength Sinus Headache Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

 Call 1-888-309-9030

Principal Display Panel

DG
health

Compare to active ingredient in Sudafed PE® Sinus Pressure + Pain*

Maximum Strength
Sinus Headache
Pain Reliever - Acetaminophen
Nasal Decongestant - Phenylephrine HCl

Relieves:     • Sinus pain & headache     • Sinus pressure
                     • Nasal & sinus congestion

Pseudoephedrine Free

24
Caplets
Non-Drowsy

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 Sudafed PE® Sinus Headache.
50844   REV0410F50208

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSIONS RIDGE
GOODLETTSVILLE, TN 37072

Maximum Strength Sinus Headache
DG 44-502

Maximum Strength Sinus Headache

Acetaminophen and Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-502
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
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
POVIDONES
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
ORANGE 17 mm 44;502 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:55910-502-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-06-23


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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