Cold and Head Congestion Severe — v3

Cold and Head Congestion Severe

8 Views

Version

v3

Effective date

September 24, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
2a410557-4aea-49b3-83c7-fae2b27162ef
Set ID
a41c62aa-90a4-4958-984f-b2fed0276c8a
Application numbers
M012
Product NDCs
79481-3572
Package NDCs
79481-3572-8
Original packager NDCs

Names & Manufacturers

Brand names
Cold and Head Congestion Severe
Generic names
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer names
Meijer Distribution, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions [PE]
Pharmacologic class (EPC)
Expectorant [EPC]
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
N0000008867, N0000009560, N0000193956
RxCUI
1243679
UNII
04JA59TNSJ, 362O9ITL9D, 495W7451VQ
UPC
0713733972567

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have liver disease diabetes difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) heart disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure thyroid disease
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

Directions do not take more than directed 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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Indications And Usage (1)

Sequence 1

Uses for the temporary relief of the following cold symptoms: headache nasal congestion minor aches and pains sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel (1)

Sequence 1

Principal display panel meijer® NDC 79481-3572-8 COMPARE TO TYLENOL® COLD + HEAD CONGESTION SEVERE ACTIVE INGREDIENTS* Cold & Head Congestion Severe ACETAMINOPHEN GUAIFENESIN PHENYLEPHRINE HCl PAIN RELIEVER/FEVER REDUCER EXPECTORANT NASAL DECONGESTANT Relieves: • Headache • Body Aches • Fever • Sore Throat • Nasal Congestion • Mucus • Chest Congestion 24 Caplets Actual Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® COLD + HEAD CONGESTION SEVERE. 50844 ORG092252708 DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com Meijer 44-527C Meijer 44-527C
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever/fever reducer Expectorant Nasal decongestant
Questions (1)

Sequence 1

Questions or comments? 1-800-426-9391
Spl Product Data Elements (1)

Sequence 1

Cold and Head Congestion Severe Acetaminophen, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSPOVIDONE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE 44;527
Stop Use (1)

Sequence 1

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.
Storage And Handling (1)

Sequence 1

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Warnings (1)

Sequence 1

Warnings Liver warning: This product contains acetaminophen. 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: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 diabetes difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) heart disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure thyroid disease 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using (1)

Sequence 1

When using this product do not exceed recommended dosage.

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Cold and Head Congestion Severe'],
 'generic_name': ['ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Meijer Distribution, Inc.'],
 'nui': ['N0000193956', 'N0000008867', 'N0000009560'],
 'package_ndc': ['79481-3572-8'],
 'pharm_class_epc': ['Expectorant [EPC]'],
 'pharm_class_pe': ['Decreased Respiratory Secretion Viscosity [PE]',
                    'Increased Respiratory Secretions [PE]'],
 'product_ndc': ['79481-3572'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1243679'],
 'spl_id': ['2a410557-4aea-49b3-83c7-fae2b27162ef'],
 'spl_set_id': ['a41c62aa-90a4-4958-984f-b2fed0276c8a'],
 'substance_name': ['ACETAMINOPHEN',
                    'GUAIFENESIN',
                    'PHENYLEPHRINE HYDROCHLORIDE'],
 'unii': ['362O9ITL9D', '495W7451VQ', '04JA59TNSJ'],
 'upc': ['0713733972567']}