OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Keep out of reach of children.
Temporarily relieves symptoms associated with the common cold, flu, hay fever
and other respiratory allergies
nasal and sinus congestion
itching of the nose or throat
minor aches and pains
sneezing and runny nose
itchy, watery eyes
headaches
LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER
DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS
WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES
IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER
DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS
EVERYDAY WHILE USING THIS PRODUCT
Directions
adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.
Do not exceed 6 doses In a 24 hour period or as directed by a doctor
children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.
Do not exceed 5 doses In a 24 hour period or as directed by a doctor
children under 6 years of ago: consult a doctor
Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product
Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, cough is accompanied by excessive phlegm (mucus), high blood pressure, thyroid disease, glaucoma, diabetes, heart disease, a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"
When using this product
marked drowsiness may occur _ excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery
If pregnant or breast feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Other Information
_ store at 15'-30'C (59'-86'F)
ACETAMINOPHEN 650 mg _ PAIN RELIEVER ; FEVER REDUCER
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg _ ANTIHISTAMINE
PHENYLEPHRINE HYDROCHLORIDE 10 mg _ NASAL DECONGESTANT
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1147619 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | 1 |
| 1147619 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | 1 |
| 1147619 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10956-813-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-25da-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10956-813-01 | REESES ONETAB COLD AND FLU | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 10956-813-30 | REESES ONETAB COLD AND FLU | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10956-813 | REESES ONETAB COLD AND FLU (ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE) TABLET [REESE PHARMACEUTICAL CO.] | 1 | Legacy NDC, 2 package rows | 20100824_628f76d8-0bcf-4eb1-a063-061ccf28ccc9.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10956-813 | 10956-813-30, 10956-813-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 36179e63-1f04-41b1-97a5-90c425259f17 | 628f76d8-0bcf-4eb1-a063-061ccf28ccc9 | 2010-08-16 | Warnings | 36179e63-1f04-41b1-97a5-90c425259f17 628f76d8-0bcf-4eb1-a063-061ccf28ccc9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.