Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Uses

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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 occur
  • pain, nasal congestion, or cough 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
  • cough comes back or occurs with 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

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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 years
  • ask a doctor

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Other information

  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #2, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

RESTORE u

NDC 57344-163-05

COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL®
COLD & FLU SEVERE

See New Warnings
Information & Directions

DAYTIME
NON-DROWSY

Severe Cold & Flu
For
Adults

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant


  • Headache/Fever/Sore Throat – Acetaminophen
  • Nasal Congestion – Phenylephrine HCl
  • Coughing – Dextromethorphan HBr
  • Chest Congestion, Clears out Mucus – Guaifenesin

24 CAPLETS

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-163
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
propylene glycol
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm AAA;1136 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 NDC:57344-163-05 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-28


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