Indications and uses
temporarily relieves these symptoms due to a cold minor aches and pains headache nasal congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever
Daytime Severe Cold and Cough Relief
- Manufacturer
- Family Dollar (FAMILY WELLNESS)
- Effective date
- 2019-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:48:17
Label at a glance#
ProductDaytime Severe Cold and Cough Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- nasal congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) 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
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
- 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.
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough accompanied by excessive phlegm (mucus)
- persistent or chronic cough 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 use more than directed (see overdose warning)
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with a fever, 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 4 hours
- chlldren under 12 years of age: do not use
Other information
- each 30 mL contains: sodium 16 mg
- store at 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltito, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Daytime
Severe Cold and Cough Relief
Acetaminophen
Pain reliever, fever reducer
Dextromethorphan HBr
Cough suppressant
Phenylephrine HCl
Nasal decongestant
Relief of:
Nasal congestion; cough; fever; body ache; sore throat; headache
Alcohol Content: 10%
Cherry Flavor
For ages 12 & over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Failure to follow the drug facts warnings could result in serious consequences.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & cough.
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Daytime Severe Cold and Cough Relief
- ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ALCOHOL
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-316 | 55319-316-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| MALTITOL | MALTITOL | D65DG142WK | CAPSULE / ORAL | 155 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET / SUBLINGUAL | 13 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CLOTH / TOPICAL | 4.2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | ELIXIR / ORAL | 120 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / OPHTHALMIC | 0.45 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / ORAL | 1200 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / ORAL | 197 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRACARDIAC | 25 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FOR SUSPENSION / ORAL | 80 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 6 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| TRISODIUM CITRATE DIHYDRATE | TRISODIUM CITRATE DIHYDRATE | B22547B95K | GRANULE, FOR SUSPENSION / ORAL | 4950 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, EFFERVESCENT / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg |
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 |
|---|---|---|---|---|---|---|
| 12262853-036d-418b-9a8e-ce5bc471333a | 34a88862-e07a-433b-ab73-e9282d5c34b6 | 2019-12-26 | Warnings | 12262853-036d-418b-9a8e-ce5bc471333a 34a88862-e07a-433b-ab73-e9282d5c34b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.