care one flu and severe cold and cough

American Sales Company

American Sales Company Nighttime Flu & Severe Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each packet)
• Purposes
• care one flu and severe cold and cough Uses
• Warnings
  • 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
  • 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 ingredients (in each packet)

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

care one flu and severe cold and cough Uses

• •temporarily relieves these symptoms due to a cold:
• •minor aches and pains
• •minor sore throat pain
• •headache
• •nasal and sinus congestion
• •runny nose
• •sneezing
• •itchy nose or throat
• •itchy, watery eyes due to hay fever
• •cough due to minor throat and bronchial irritation
• •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 5 packets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •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

• •if you have ever had an allergic reaction to this product or any of its ingredients
• •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• •with any other product containing diphenhydramine, even one used on skin
• •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.
• •to make a child sleepy

Ask a doctor before use if you have

• •liver disease
• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •glaucoma
• •trouble urinating due to an enlarged prostate gland
• •a breathing problem such as emphysema or chronic bronchitis
• •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 sedatives or tranquilizers
• •taking the blood thinning drug warfarin

When using this product

• •do not exceed recommended dosage
• •avoid alcoholic drinks
• •marked drowsiness may occur
• •alcohol, sedatives and tranquilizers may increase drowsiness
• •be careful when driving a motor vehicle or operating machinery
• •excitability may occur, especially in children

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
• •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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 (see overdose warning)
• •take every 4 hours; do not take more than 5 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.

care one flu and severe cold and cough Other information

• •each packet contains: potassium 10 mg and sodium 25 mg
• •phenylketonurics: contains phenylalanine 13 mg per packet
• •store at 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #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

NIGHTTIME FLU & SEVERE COLD & COUGH

Pain Reliever-Fever Reducer (Acetaminophen)

Antihistamine/Cough Suppressant (Diphenhydramine HCl)

Nasal Decongestant (Phenylephrine HCl)

HONEY LEMON INFUSED WITH WHITE TEA FLAVORS

Nasal Congestion

Cough

Runny Nose

Sneezing

Body Ache

Sore Throat Pain

Headache/Fever

6 PACKETS