Nighttime Severe Cold And Flu Maximum Strength Mini Softgels Capsule, Liquid Filled
FDA Label NDC 83059-0074

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl - 5 mg

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains
• headache
• cough
• nasal and sinus congestion
• sore throat
• temporarily reduces fever
• runny nose, sneezing

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock.

If a skin or general allergic 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.
Do not use in children or to sedate children.

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
• if you have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough with excessive phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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. These could be signs of a serious condition
• nervousness, dizziness, or sleeplessness occurs

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

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.

• 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

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

1-800-373-6981

anhydrous citric acid, FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, mica, N-butyl alcohol, polyethylene glycol-400, propylene glycol, povidone (PVP K30), purified water, shellac, sorbitol solution, titanium dioxide

mini softgels

Nighttime
Severe Cold & Flu 

Maximum Strength

Carton