FDA Label for Nightime Cold And Flu

Drug Facts

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:
• cough due to minor throat and bronchial irritation
• sore throat n headache n minor aches and pains
• fever
• runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hours, 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, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur n avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness

Otc - Stop Use

Stop use and ask a doctor if
• pain 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
These could be signs of a serious condition

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.

Overdosage

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

• take only as directed - see Overdose warning.
• do not exceed 4 doses per 24 hours

adults & children 12 years & over	2 softgels with water every 6 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other Information

• store between 15°C to 30°C (59°F to 86°F)
• avoid excessive heat

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, Lecithin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792