Cold and Flu Severe Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide DEXTROMETHORPHAN Doxylamine Succinate DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 FD&C Blue NO. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone K30 Propylene Glycol Water Sodium Hydroxide Titanium Dioxide 789 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

Cold and Flu Severe Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide DEXTROMETHORPHAN Doxylamine Succinate DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 FD&C Blue NO. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone K30 Propylene Glycol Water Sodium Hydroxide Titanium Dioxide 789

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each softgel) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant
Inactive Ingredients
Inactive ingredients D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol povidone K30 propylene glycol purified water sodium hydroxide sorbitol sorbitan solution titanium dioxide
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: oval Color: green Imprint: 789

Identifiers & Packaging

Container Type BOX
Packaging

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton NDC: 36800-827-24 *Compare to the active ingredients in Vicks ® Nyquil™ Severe Cold & Flu MAXIMUM STRENGTH RELIEF Night Time Cold & Flu Relief SEVERE PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr ANTIHISTAMINE - DOXYLAMINE SUCCINATE NASAL DECONGESTANT - PHENYLEPHRINE HCl • Headache, Fever, Sore Throat, Minor Aches & Pains • Sinus Congestion & Pressure • Runny Nose & Sneezing • Cough 24 SOFTGELS actual size PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton NDC: 36800-827-24 *Compare to the active ingredients in Vicks ® Nyquil™ Severe Cold & Flu MAXIMUM STRENGTH RELIEF Night Time Cold & Flu Relief SEVERE PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr ANTIHISTAMINE - DOXYLAMINE SUCCINATE NASAL DECONGESTANT - PHENYLEPHRINE HCl • Headache, Fever, Sore Throat, Minor Aches & Pains • Sinus Congestion & Pressure • Runny Nose & Sneezing • Cough 24 SOFTGELS actual size PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

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 do not exceed 8 softgels per 24 hours adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 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 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. 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 glaucoma a sodium-restricted diet trouble urinating due to enlarged prostate gland 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 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 In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Active ingredients (in each softgel) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine HCl 5 mg 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 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 20-25°C (68-77°F) protect from light, heat and moisture

Questions

Questions? Call toll free: 1-888-423-0139


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