Cold Head Congestion Severe: Package Insert and Label Information

COLD HEAD CONGESTION SEVERE- acetaminophen, guaifenesin and phenylephrine hydrochloride tablet, coated
HEB

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Uses

  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • sinus congestion and pressure
  • 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

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, perists 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

Other information

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

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Compare to Tylenol Cold + Head Congestion Severe Caplets active ingredients

NDC 37808-775-02

HEB

Cold & Head Congestion Severe

Acetaminophen / Pain Reliever/Fever Reducer

Guaifenesin / Expectorant

Phenylephrine HCl / Nasal Decongestant

Cold, Head Congestion

COOL TASTE

For Adults

Relief of:

Head & Body Aches, Fever, Sore Throat

Nasal Congestion, Mucus & Chest Congestion

actual size

24 CAPLETS

image description
(click image for full-size original)
COLD HEAD CONGESTION SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-775
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, PREGELATINIZED CORN
PROPYLENE GLYCOL
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor MINT Imprint Code AAA;1119
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-775-02 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (37808-775-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/01/2018
Labeler — HEB (007924756)

Revised: 10/2019 HEB

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