Indications and uses
▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains
Multi Symptom Severe Cold
- Manufacturer
- FAMILY DOLLAR SERVICES INC
- Effective date
- 2023-07-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:37
Label at a glance#
ProductMulti Symptom Severe Cold
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 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 of age and over One packet Children under 12 years of age 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 ...
Storage and handling
▪ each packet contains : potassium 6 mg ▪ Aspartame free, sodium free ▪ store at room temperature. Protect from excessive heat and moisture.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each packet)
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
Purposes
Pain reliever / fever reducer
Cough Suppressant
Nasal Decongestant
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
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:
- 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 a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.
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
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 care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 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
- 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 of age and over | One packet |
Children under 12 years of age | 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.
Other information
- each packet contains: potassium 6 mg
- Aspartame free, sodium free
- store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions or Comments
1-866-467-2748
Principal Display
Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold*
NDC 55319-547-06
MULTI-SYMPTOM
SEVERE COLD
Acetaminophen
Pain Reliever/ Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Dye Free
- Relieves
- cough
- Nasal congestion
- Sore throat pain
- Headache
- Body ache
- Fever
Honey Lemon
6 PACKETS
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Severe Cold.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 1 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 1 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 1 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-547-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9fa7-d83d-e063-dadaa90ab31f | Multi-Symptom Severe Cold Honey Lemon Flavor 6 Packets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-547-06 | Multi Symptom Severe Cold | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Multi Symptom Severe Cold
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- CARAMEL
- MALTODEXTRIN
- POTASSIUM CHLORIDE
- SILICON DIOXIDE
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-547 | 55319-547-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| a8d73098-aa20-485f-8942-2d9f56fd7887 | a8d73098-aa20-485f-8942-2d9f56fd7887 | 2023-07-13 | Warnings | a8d73098-aa20-485f-8942-2d9f56fd7887 a8d73098-aa20-485f-8942-2d9f56fd7887 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.