ASP Daytime PE ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD. FDA Approved Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation nasal congestion sore throat headache minor aches/pains fever
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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 10 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients FD&C Red #40 FD&C Yellow #6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol special titanium dioxide Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan Hubei 430206 China
Strengths
325 mg 10 mg 5 mg
Quantities
4000 capsules
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Cough Due To Minor Throat Bronchial Irritation Nasal Congestion Sore Throat Headache Minor Aches Pains Fever
Pill Appearance
Shape: capsule Color: orange Imprint: PC9

Identifiers & Packaging

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

PRINCIPAL DISPLAY PANEL - Shipping Label ASP Daytime PE Capsules Quantity : 4000 Capsules NDC. No : 53345-052-01 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" Shipper Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Shipping Label ASP Daytime PE Capsules Quantity : 4000 Capsules NDC. No : 53345-052-01 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" Shipper Label

Overview

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation nasal congestion sore throat headache minor aches/pains fever

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation nasal congestion sore throat headache minor aches/pains fever

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 older Swallow 2 softgels with water every 4 hours Children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking NIGHTTIME and DAYTIME products, 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 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, persists more than 2 days, occurs with or is 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 diabetes thyroid disease high blood pressure cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) 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 care 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 and for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/ fever reducer Cough suppressant 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

Stop Use & Ask a Doctor

Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) 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 15°-30°C (59°-86°F)


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