Label: CONRX PAIN RELIEVER SINUS HEADACHE- phenylephrine hydrochloride and acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68737-240-24 - Packager: Eagle Distributors,Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 7, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
- Directions
- Other information
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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
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PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box
See New Warnings Information & Directions
Compare to the Active Ingredients in
EXCEDRIN*® SINUS
HEADACHEConRx®
PAIN RELIEVER
SINUS
HEADACHEAcetaminophen and Phenylephrine HCl
Aspirin Free • Pain Reliever / Nasal Decongestant
TO OPEN
PUSH IN TAB AND PULL OUTCompare to the Active Ingredients in
EXCEDRIN® SINUS
HEADACHE2 Caplets Each Pouch
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INGREDIENTS AND APPEARANCE
CONRX PAIN RELIEVER SINUS HEADACHE
phenylephrine hydrochloride and acetaminophen tabletProduct 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)