Daytime Cold and Flu Mini Softgels ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL SHIELD PHARMACEUTICALS CORP FDA Approved Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache n cough nasal congestion sore throat sinus congestion and pressure temporarily reduces fever
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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 10 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients FD&C Yellow No. 6 gelatin glycerin isopropyl alcohol MCT Oil polyethylene glycol-400 propylene glycol povidone purified water silver sheen sorbitol solution
Strengths
325 mg 10 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Or Flu Minor Aches And Pains Headache N Cough Nasal Congestion Sore Throat Sinus Congestion And Pressure Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: orange Imprint: SDM

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0383059000161
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL Daytime Cold & Flu Multi-Symptom Relief mini softgels Carton Daytime minis

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Daytime Cold & Flu Multi-Symptom Relief mini softgels Carton Daytime minis

Overview

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache n cough nasal congestion sore throat sinus congestion and pressure temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache n cough nasal congestion sore throat sinus congestion and pressure temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults & children 12 yrs & over: take 2 Softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor children under 12 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 • pain, nasal congestion 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.

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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