Indications and uses
temporarily relieves these symptoms due to a cold minor aches and pains headache sore throat nasal congestion cough due to minor throat and bronchial irritation temporarily reduces fever
Severe cold and cough relief
- Manufacturer
- AAFES/Your Military Exchanges | P & L Development, LLC
- Effective date
- 2019-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:09:05
Label at a glance#
ProductSevere 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 exceed 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 children 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
Dextromethoprhan HBr 20 mg
Phenlyephrine 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
- sore throat
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allery 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
- with any other drug containing acetaminophen (prescription or 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 an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if the user has
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much 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 exceed recommended dosage.
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occurs
- 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: 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 exceed 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
- children under 12 years of age: do not use
Other information
- each 30 mL contains: sodium 16 mg
- store between 20-25ºC (68-77ºF)
- do not refrigerate
Inactive ingredients
acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C Blue# 1, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate.
Questions or comments?
Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
Principal Display Panel
Compare to the active ingredients in Theraflu® Daytime Severe cold & cough*
Severe cold and cough relief
Daytime
Acetaminophen 650 mg/ Pain reliever/ fever reducer
Dextromethorphan HBr 20 mg/ Cough Suppressant
Phenylephrine HCl 10 mg/ Nasal Decongestant
cough
nasal congestion
aches, fever & sore throat
Manufactured for your Military Exchanges
By: PL Developments, 11865 S. Alameda st., Lynwood, CA 90262
8.3 fl oz (245 mL)
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime severe cold and cough
Package Label
Products#
Every source-derived product name is available through these pages.
- Severe cold and cough relief
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ALCOHOL
- CITRIC ACID MONOHYDRATE
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55301-316 | 55301-316-08 |
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 |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|
| a2ec1edf-a687-40de-be4c-8bcaeff1cdf3 | 7f029f38-4a06-4aa8-82cb-c64da4bedac8 | 2019-10-01 | Warnings | a2ec1edf-a687-40de-be4c-8bcaeff1cdf3 7f029f38-4a06-4aa8-82cb-c64da4bedac8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.