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

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flu and severe cold and cough

H E B

HEB Flu & Severe Cold & Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each packet)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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
  • •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.
  • •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

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
  • •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) 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 Liver warning
  • •take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor

Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet

  • •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.

flu and severe cold and cough Other information

  • •each packet contains: potassium 5 mg and sodium 42 mg
  • •phenylketonurics: contains phenylalanine 17 mg per packet
  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue #1, FD&C red #40, flavor, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Theraflu® Daytime Severe Cold & Cough active ingredients

FLU & SEVERE COLD & COUGH

Daytime

Pain Reliever-Fever Reducer (Acetaminophen)

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

Nasal & Sinus Congestion

Cough

Body Ache

Sore Throat Pain

Headache

Fever

Berry Infused with Menthol Flavors

See New Warnings and Directions

GLUTEN FREE

flu and severe cold and cough

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-444
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
ASPARTAME
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
maltodextrin
SODIUM CITRATE
SUCROSE
TRIBASIC CALCIUM PHOSPHATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 POUCH
2 NDC:37808-444-91 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-02-04


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