Label: CONRX COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68737-232-16 - 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 February 12, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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.
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
- persistent or 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 more than 7 days
- fever gets worse or lasts 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 a serious condition.
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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 50 Pouch Box
See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol® Cold*
Head CongestionConRx™
SEVERE
COLDSore throat - Cough - Headache - Nasal Congestant
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:68737-232 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) DOCUSATE SODIUM (UNII: F05Q2T2JA0) 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 YELLOW 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:68737-232-16 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 02/15/2013 Labeler - Eagle Distributors,Inc. (929837425)