Nighttime Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD. 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 ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 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 Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan Hubei 430206 China
Strengths
325 mg 15 mg 6.25 mg
Quantities
4000 capsules
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: 660

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

PRINCIPAL DISPLAY PANEL - Shipping Label NIGHTTIME COLD AND FLU CAPSULES Quantity : 4000 Capsules NDC. No : 53345-026-01 IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 15-30°C (59-86°F) CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING" Shipping Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Shipping Label NIGHTTIME COLD AND FLU CAPSULES Quantity : 4000 Capsules NDC. No : 53345-026-01 IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 15-30°C (59-86°F) CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING" Shipping Label

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 - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 years of age and over take 2 softgels with water every 6 hours children 4 to 12 years of age ask a doctor children under4 years o9f age 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 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Purpose

Purpose Pain reliever/ fever reducer Cough suppressant Antihistamine

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 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 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. 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 children even if you do not notice any signs or symptoms.

Storage & Handling

Other information store at room temperature 15°-30°C (59°-86°F)


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