Nighttime Cold and Flu Max Softgels ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL TOPCO ASSOCIATES, LLC FDA Approved Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg Phenylephrine HCl - 5 mg
Inactive Ingredients
Inactive ingredients FD&C Blue No. 1 FD&C Red No. 40 FD&C Yellow No. 10 gelatin glycerin isopropyl alcohol MCT Oil polyethylene glycol-400 propylene glycol povidone purified water silver sheen sorbitol solution
Strengths
325 mg 15 mg 6.25 mg 5 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Cough Due To Minor Throat Bronchial Irritation Sore Throat Headache Minor Aches Pains Fever Runny Nose Sneezing
Pill Appearance
Shape: capsule Color: green Imprint: SD15

Identifiers & Packaging

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

PRINCIPAL DISPLAY PANEL Nighttime Cold & Flu Max Softgels Carton Nighttime minis

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Nighttime Cold & Flu Max Softgels Carton Nighttime minis

Overview

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

Dosage & Administration

Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water every 6 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 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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.
Purpose

Purpose 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.

When Using

When using this product • do not use more than directed n 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, & tranquilizers may increase drowsiness

Stop Use & Ask a Doctor

Stop use and ask a doctor if • pain 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 • 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Questions

Questions or comments? 1-800-373-6981 (toll-free)


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