Multi Symptom Severe Cold ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL RARITAN PHARMACEUTICALS INC FDA Approved Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg
Inactive Ingredients
Inactive ingredients citric acid caramel flavors maltodextrin potassium chloride silica sucralose sucrose Questions or Comments 1-866-467-2748
Strengths
500 mg 20 mg 10 mg
Quantities
6 pack
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Minor Sore Throat Pain Headache Nasal And Sinus Congestion Cough Due To Minor Throat And Bronchial Irritation Temporarily Reduces Fever

Identifiers & Packaging

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

Principal Display DRx Choice® NDC# 68163-547-06 Compare to the active ingredients in Theraflu ® Multi-Symptom Severe Cold* MULTI-SYMPTOM Severe Cold ACETAMINOPHEN - Pain Reliever/ Fever Reducer DEXTROMETHORPHAN HBr - Cough Suppressant PHENYLEPHRINE HCl - Nasal Decongestant Aspartame Free Dye free Sodium free Relieves Body ache Cough Fever Headache Nasal congestion Sore throat pain Green Tea & Honey Lemon Flavors Infused with Menthol & Green Tea Flavors 6 PACKETS TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu ® Multi-Symptom Severe Cold. Multi Symptom Severe Cold Acetaminphen

Package Descriptions
  • Principal Display DRx Choice® NDC# 68163-547-06 Compare to the active ingredients in Theraflu ® Multi-Symptom Severe Cold* MULTI-SYMPTOM Severe Cold ACETAMINOPHEN - Pain Reliever/ Fever Reducer DEXTROMETHORPHAN HBr - Cough Suppressant PHENYLEPHRINE HCl - Nasal Decongestant Aspartame Free Dye free Sodium free Relieves Body ache Cough Fever Headache Nasal congestion Sore throat pain Green Tea & Honey Lemon Flavors Infused with Menthol & Green Tea Flavors 6 PACKETS TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu ® Multi-Symptom Severe Cold. Multi Symptom Severe Cold Acetaminphen

Overview

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage & Administration

Directions do not use more than directed take every 4 hours, while symptoms persist. do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 a 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 trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purposes Pain reliever/Fever reducer Cough Suppressant Nasal Decongestant

Do Not Use

Do not use in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 a MAOI, ask a doctor or pharmacist before taking this product.

When Using

When using this product do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, 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 right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information each packet contains: potassium 6 mg store at room temperature. Protect from excessive heat and moisture.

Questions

Questions or Comments 1-866-467-2748


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