Daytime Cold And Flu Multi Symptom Mini Softgels Capsule, Liquid Filled
FDA Label NDC 83059-0094

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Daytime Cold And Flu Multi Symptom Mini Softgels (NDC 83059-0094). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

Active Ingredient (In Each Softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

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

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.

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product
• do not use more than directed.

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - 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.

Directions

take only as directed  do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over2 Softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other Information

• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.

Questions Or Comments?

1-800-373-6981 (toll-free)

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

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mini softgels
smaller size, same strength

Daytime
Cold & Flu 

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