FDA Label for Daytime Nighttime Severe Cold And Flu

Otc - Active Ingredient

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Indications & Usage

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation
minor aches & pains
headache
fever
sore throat
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Warnings

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

more than 8 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day 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 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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Ask Doctor/Pharmacist

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

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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

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

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

Storage And Handling

Other information

do not exceed 25°C

Inactive Ingredient

Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Otc - Questions

Questions or comments?

Call 1-877-290-4008

Package Label.Principal Display Panel

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