Daytime

Taro Pharmaceuticals U.S.A., Inc.

Daytime Flu and Severe

FULL PRESCRIBING INFORMATION: CONTENTS*

• Daytime Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Daytime Other information
• Inactive ingredients
• Questions or Comments?
• PRINCIPAL DISPLAY PANEL - 6 Packet Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Daytime Uses

• temporarily relieves:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation
• temporarily reduces fever

Warnings

Liver warning

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

• more than 6 packets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.

Do not use

• in a child under 4 years of age
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• symptoms do not get better or worsen
• new symptoms occur
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor

• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Daytime Other information

• each packet contains: potassium 4 mg, sodium 27 mg
• phenylketonurics: contains phenylalanine 34 mg per packet
• store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and moisture.

Inactive ingredients

acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue No. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or Comments?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NDC 51672-2112-7

Compare to the active
ingredient in Theraflu^®
Daytime Severe Cold & Cough*

See New Warnings
Information

Daytime

Flu & Severe
Cold & Cough

Acetaminophen - Pain reliever/fever reducer
Dextromethorphan HBr - Cough suppressant
Phenylephrine HCl - Nasal decongestant

• Nasal & Sinus
  Congestion
• Cough
• Body Ache
• Sore Throat
  Pain
• Headache
• Fever

Berry Infused with
Menthol & Green Tea Flavors

6 Packets