care one flu and severe cold and cough

American Sales Company

American Sales Company Flu and Severe Cold and Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each packet)
• Purpose
• care one flu and severe cold and cough Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• care one flu and severe cold and cough Other information
• Inactive ingredients
• Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each packet)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

care one flu and severe cold and cough Uses

• temporarily relieves
• minor aches and pains
• minor sore throat
• 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 for this product
• 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

• 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.

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
• a sodium-restricted diet

taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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 professional before use.

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.

Directions

• do not use more than directed – see Liver warning
• take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
• adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
• children under 12 years of age: consult a doctor
• if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

care one flu and severe cold and cough Other information

• each packet contains: potassium 5 mg and sodium 41 mg
• phenylketonurics: contains phenylalanine 17 mg per packet
• store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredients in Theraflu® Severe Cold & Cough

Daytime

Flu & Severe Cold & Cough

Pain Reliever–Fever Reducer (Acetaminophen)

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

Berry Infused with Menthol & Green Tea Flavors

Nasal Congestion

Sore Throat

Headache

Body Ache

Fever

Cough

See New Warnings Information