CONRX PAIN RELIEVER SINUS HEADACHE- phenylephrine hydrochloride and acetaminophen tablet

ConRX Pain Reliever Sinus Headache by

Drug Labeling and Warnings

ConRX Pain Reliever Sinus Headache by is a Otc medication manufactured, distributed, or labeled by Eagle Distributors,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
Acetaminophen 325 mg	Pain reliever
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves:
  • headache
  • minor aches and pains
  • nasal congestion
  • sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes

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

• if you are allergic to acetaminophen
• 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 heart disease thyroid disease:
  • trouble urinating due to an enlarged prostate gland
  • high blood pressure
  • diabetes

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• any new symptoms occur
• you get nervous, dizzy, or sleepless
• painful area is red or swollen
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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
• adults and children 12 years and over: take 2 caplets every 4 hours; not more than 12 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, carnauba wax, corn starch, FD&C blue # 1, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, stearic acid, titanium dioxide, talc,gelatin, polyethylene glycol sodium starch glycolate, sodium benzoate, hydroxypropylmethyl cellulose

Questions or comments?

1-855-619-7900

PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

See New Warnings Information & Directions
Compare to the Active Ingredients in
EXCEDRIN*® SINUS
HEADACHE

ConRx®

PAIN RELIEVER
SINUS
HEADACHE

Acetaminophen and Phenylephrine HCl

Aspirin Free Pain Reliever / Nasal Decongestant

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
EXCEDRIN® SINUS
HEADACHE

2 Caplets Each Pouch

INGREDIENTS AND APPEARANCE

CONRX PAIN RELIEVER SINUS HEADACHE 
phenylephrine hydrochloride and acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68737-240
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg

Inactive Ingredients
Ingredient Name	Strength
Benzoic Acid (UNII: 8SKN0B0MIM)
Carnauba Wax (UNII: R12CBM0EIZ)
Starch, Corn (UNII: O8232NY3SJ)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Sodium Benzoate (UNII: OJ245FE5EU)
light mineral oil (UNII: N6K5787QVP)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polysorbate 20 (UNII: 7T1F30V5YH)
Povidones (UNII: FZ989GH94E)
Propylene Glycol (UNII: 6DC9Q167V3)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
Stearic acid (UNII: 4ELV7Z65AP)
Titanium dioxide (UNII: 15FIX9V2JP)
Talc (UNII: 7SEV7J4R1U)
Gelatin (UNII: 2G86QN327L)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)
Hypromelloses (UNII: 3NXW29V3WO)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	CRX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68737-240-24	50 in 1 BOX
1		2 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2014

Labeler - Eagle Distributors,Inc. (929837425)