Indications and uses
• Temporarily relieves these symptoms due to cold: o minor aches and pains o minor sore throat pain o headache o nasal and sinus congestion o cough due to minor throat and bronchial irritation • Temporarily reduces fever
Multi-Symptom Severe Cold
- Manufacturer
- Cellchem Pharmaceuticals Inc | Laboratoires Confab Inc
- Effective date
- 2022-11-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:45:56
Label at a glance#
ProductMulti-Symptom Severe Cold
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
• do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years and over one packet children under 12 years do not use • 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....
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active Ingredients (in each packet) Purpose
Acetaminophen 500 mg.........................................Pain reliever/Fever reducer
Dextromethorphan hydrobromide 20 mg.........................................Cough suppressant
Phenylephrine Hydrochloride 10 mg......................................Nasal decongestant
Uses
- Temporarily relieves these symptoms due to 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
INDICATIONS & USAGE SECTION
Relieves:
- Nasal congestion
- Sore throat pain
- Cough
- Headache
- Body ache
- 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.
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- in children under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription and non-prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR/PHARMACIST SECTION
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
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health care professional before use.
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 rash or headache that lasts. These could be signs of a serious condition.
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.
WARNINGS SECTION
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE.
DO NOT DISCARD.
DO NOT USE IF SEALED PACKET IS TORN OR BROKEN
Directions
- do not use more than directed
- take every 4 hours, while symptoms persist.
Do not take more than 6 packets in 24 hours unless directed by a doctor.
Age | Dose |
adults and children 12 years and over | one packet |
children under 12 years | do not use |
- 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.
SPL UNCLASSIFIED SECTION
Other Information
- each packet contains: calcium 130 mg, potassium 10 mg, sodium 20 mg.
- phenylketonurics: contains phenylalanine 12 mg per packet.
- store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.
Inactive ingredients
Acesulfame potassium, anhydrous citric acid, aspartame, calcium phosphate dibasic, caramel, D&C Yellow #10, flavors, maltodextrin, silicon dioxide, sodium citrate, starch, sucrose.
Questions, Comments or Adverse Reactions?
You may report serious side effects to: +1 844-481-8884
Serious side effects can also be reported to: drugsafety@cellchempharma.ca
Distributed by:
CellChem Pharmaceuticals Inc.
Unit 1, 30 Concourse Gate
Nepean, Ontario K2E 7V7
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Multi-Symptom Severe Cold
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- D&C YELLOW NO. 10
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- CARAMEL
- MALTODEXTRIN
- SILICON DIOXIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- STARCH, CORN
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73147-3192 | 73147-3192-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fc046613-099b-4b6d-acc1-3c26712b2401 | b6dddc7c-370f-447b-b24e-8cc68b352c4c | 2022-11-28 | Warnings | fc046613-099b-4b6d-acc1-3c26712b2401 b6dddc7c-370f-447b-b24e-8cc68b352c4c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.