Label: CONRX DAYTIME- phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, and guaifenesin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68737-238-22 - 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 January 21, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor
- throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, 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 wheather a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking 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
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- 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.
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Directions
- take only as directed - see Overdose warning
- do no exceed 4 doses per 24 hours
- adult and children 12 years and over, 2 Caplets with water every 4 hours
- children 4 to under 12 years, ask a doctor
- children under 4 years, do not use
- Other information
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Inactive ingredients
sodium starch glycolate, croscarmellose sodium, FD&C Yellow No. 6, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidones, corn starch, gelatin, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, sodium benzoate hydroxypropylmethyl cellulose
- Questions?
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PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box
Compare to the Active Ingredients in
DayQuil®
SEVEREConRx®
DayTime
COLD & FLUAcetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
MAX
STRENGTHNon-Drowsy
- Headache, Fever, Sore Throat, Minor Aches & Pains
- Nasal/Sinus Congestion & Sinus Pressure
- Cough
- Chest Congestion
2 Caplets Each Pouch
TO OPEN
PUSH IN TAB AND PULL OUTCompare to the Active Ingredients in
DayQuil®
SEVERE2 Caplets Each Pouch
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INGREDIENTS AND APPEARANCE
CONRX DAYTIME
phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, and guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68737-238 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Maltodextrin (UNII: 7CVR7L4A2D) Cellulose, Microcrystalline (UNII: OP1R32D61U) Polysorbate 80 (UNII: 6OZP39ZG8H) Povidones (UNII: FZ989GH94E) Polyethylene Glycols (UNII: 3WJQ0SDW1A) Silicon dioxide (UNII: ETJ7Z6XBU4) Talc (UNII: 7SEV7J4R1U) Titanium dioxide (UNII: 15FIX9V2JP) Stearic Acid (UNII: 4ELV7Z65AP) Polyvinyl Alcohol (UNII: 532B59J990) Starch, Corn (UNII: O8232NY3SJ) Gelatin (UNII: 2G86QN327L) Magnesium Stearate (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Sodium Benzoate (UNII: OJ245FE5EU) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color ORANGE 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:68737-238-22 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)