Night Time Severe Cold and Flu Relief ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE DOXYLAMINE SUCCINATE DEXTROMETHORPHAN HYDROBROMIDE PURACAP PHARMACEUTICAL LLC FDA Approved Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol special and white edible ink
Strengths
325 mg 10 mg 6.25 mg 5 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Nasal Congestion Sinus Congestion Pressure Cough Due To Minor Throat Bronchial Irritation Cough To Help You Sleep Minor Aches Pains Headache Fever Sore Throat Runny Nose Sneezing Reduces Swelling Of Nasal Passages Temporarily Restores Freer Breathing Through The Nose Promotes Nasal And Or Sinus Drainage
Pill Appearance
Shape: capsule Color: green Imprint: PC22

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL - Carton Label Night Time Severe Cold & Flu Relief 24 Softgels Acetaminophen 325mg, Phenylephrine hydrochloride 5mg, Doxylamine succinate 6.25mg, Dextromethorphan hydrobromide 10mg NDC 51013-175-04 *Compare to the active ingredients in Vicks® NyQuil® Severe Cold and Flu DG Night severe cold flu carton label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Carton Label Night Time Severe Cold & Flu Relief 24 Softgels Acetaminophen 325mg, Phenylephrine hydrochloride 5mg, Doxylamine succinate 6.25mg, Dextromethorphan hydrobromide 10mg NDC 51013-175-04 *Compare to the active ingredients in Vicks® NyQuil® Severe Cold and Flu DG Night severe cold flu carton label

Overview

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Dosage & Administration

Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs and over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use 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 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. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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. to make a child sleep Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness 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

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine 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. to make a child sleep

When Using

When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

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 and avoid excessive heat

Questions

Questions or comments? Call toll free: 1-888-309-9030


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