Label: CONRX COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68737-227-11 - Packager: Eagle Distributors,Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 10, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
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.
- 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
- a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts for more than 7 days
- fever gets more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of serious conditions.
- Overdose warning
- Directions
- Other Information
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Inactive ingredients
Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, D & C yellow #10 aluminium lake ,Titanium Dioxide.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 50 Pouch Carton
NDC: 68737-227-11
Compare to the Active Ingredients in
Tylenol ® Cold
Head Congestion*ConRx
COLD
SEVERE Sore throat -Cough - Headache- Acetaminophen Sore throat
- Dextromethorphan HBr Cough
- Guaifenesin Chest Congestion
- Phenylephrine HCl Nasal Congestion
TO OPEN
PUSH IN TAB AND PULL OUTCompare to the Active Ingredients in
Tylenol®Cold
Head Congestion*50 Pouches of 2 Caplets Each
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INGREDIENTS AND APPEARANCE
CONRX COLD
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68737-227 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EDETATE DISODIUM (UNII: 7FLD91C86K) BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATE (UNII: 772Y8KZU65) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K90 (UNII: RDH86HJV5Z) GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) D&C YELLOW No. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68737-227-11 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 07/10/2012 Labeler - Eagle Distributors,Inc. (929837425)