FDA Label for Daytime Cold And Flu Multi Symptom Relief

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

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

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

butylated hydroxyanisole, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, polyethylene glycol-400, propylene glycol, propylparaben, povidone, purified water, sorbitol

Principal Display Panel

ValuRx

Compare to the Active Ingredients in Alka-Seltzer Plus® Cold & Flu Maximum Strengths

Nighttime Cold & Flu

Multi-Symptom Relief

Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl

• Headache, Fever, Sore Throat,
• Minor Aches & Pain
• Nasal Congestion,
• Sinus Pressure
• Cough

Carton