FDA Label for Daytime Cold And Flu

Other

Drug Facts

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Purpose

Pain Reliever/Fever Reducer

Cough Suppressant

Uses

Temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever

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 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Ask A Doctor Before Use If You Have

• liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - When Using

When using this product do not exceed recommended dose.

Stop Use And Ask A Doctor If

• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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.

Overdose Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Take only as directed (see overdose warning)
• Do not take more than 4 doses in 24 hours.

adults and children 12 years and over	2 softgels with water every 4 hours
children 4 to under 12 years	consult a doctor
children under 4 years	do not use

Other Information

• Store at 15° - 30 °C (59°- 86 °F)
• Read all product information before using.
• Tamper evident: Do not use if carton is open or blister unit is broken.

Inactive Ingredients

FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink.

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime Cold and Flu Capsules (PE free)

Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg

NDC 53345-056-01

Caution: for further manufacturing, processing or repackaing

Daytime Cold and Flu Capsules (PE free) - 1