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: PC10

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 : 53345-006-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" NightTime Capsules Bulk Label PLD Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Shipping Label NIGHTTIME COLD AND FLU CAPSULES Quantity : 4000 Capsules NDC. No : 53345-006-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" NightTime Capsules Bulk Label PLD 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 Swallow 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 If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure 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 with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists 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

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 exceed the recommended dosage do not use for more than 7 days excitability may occur especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and Ask a doctor if you get nervous, dizzy, or sleepless swelling or redness is present symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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) and avoid excessive heat this product does not contain phenylpropanolamine (PPA)


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