care one flu and severe cold description, usages, side effects, indications, overdosage, supplying and lots more!

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care one flu and severe cold

American Sales Company

American Sales Company Flu and Severe Cold Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each packet)

Acetaminophen 650 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

care one flu and severe cold Uses

  • temporarily relieves these symptoms due to a cold or flu:
  • headache
  • minor aches and pains
  • sore throat
  • nasal and sinus congestion
  • 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

  • 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
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

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
  • pain or nasal congestion 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

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; not to 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 4 to under 12 years of age consult a doctor
children under 4 years of age do not use
  • 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 Other information

  • each packet contains: sodium 42 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, citric acid, colloidal silicon dioxide, D&C yellow no. 10, FD&C yellow no. 6, flavors, lecithin, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredients in Theraflu® Daytime Severe Cold

Daytime

Flu & Severe Cold

Pain Reliever-Fever Reducer (Acetaminophen)

Nasal Decongestant (Phenylephrine HCl)

Natural Lemon Flavor

Nasal Congestion

Sore Throat

Headache

Body Ache

Fever

See New Warnings Information

care one flu and severe cold
Flu and Severe Cold Carton Image 1 Flu and Severe Cold Carton Image 2

care one flu and severe cold

Acetaminophen, Phenylephrine hydrochloride POWDER, FOR SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-552
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
maltodextrin
SODIUM CITRATE
SUCROSE
TRIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16000 in 1 PACKET
2 NDC:41520-552-91 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-08-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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