Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE K30 FD&C YELLOW NO. 6 TITANIUM DIOXIDE GELATIN GLYCERIN SORBITOL WATER IS4
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - Shipping Label Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules Each Softgel Contains: (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg) LOT NO: DRUM NO: MFG DATE: QUANTITY: NDC NO: 55629-015- EXP DATE: WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. Shipper Label
- PRINCIPAL DISPLAY PANEL - Shipping Label Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules Each Softgel Contains: (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg) LOT NO: DRUM NO: MFG DATE: QUANTITY: NDC NO: 55629-015- EXP DATE: WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. Shipper Label
Overview
Uses temporarily relieves common cold/flu symptoms: ο nasal congestion ο sinus congestion & pressure ο cough due to minor throat & bronchial irritation ο minor aches & pains ο headache ο fever ο 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.
Indications & Usage
Uses temporarily relieves common cold/flu symptoms: ο nasal congestion ο sinus congestion & pressure ο cough due to minor throat & bronchial irritation ο minor aches & pains ο headache ο fever ο 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.
Dosage & Administration
Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults & children 12 years of age and over 2 softgels with water every 4 hours Children under 12 years of age ask a doctor When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
Warnings & Precautions
Warnings: Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 softgels 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not use more than directed 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. 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.
Purpose
Purpose Pain reliever/ fever reducer Cough suppressant Expectorant Nasal decongestant
Do Not Use
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.
When Using
When using this product do not use more than directed
Stop Use & Ask a Doctor
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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other Information: store at room temperature 59°-86°F (15°-30°C)
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