![ACETAMINOPHEN CONGESTION AND PAIN (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]](https://medic.hrt.org//dailymed/images/29bd1c43-fe8d-45d1-ac7b-b8d991f47f38/272-5c-acetaminophen.jpg)
| NDC | 0904-6760-24 |
| Set ID | 29bd1c43-fe8d-45d1-ac7b-b8d991f47f38 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Major Pharmaceuticals |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
- •
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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- headache
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- sinus congestion and pressure
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- nasal congestion
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- minor aches and pains
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- helps decongest sinus openings and passages
- •
- promotes sinus drainage
- •
- helps clear nasal passages
- •
- temporarily reduces fever
- 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:
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- skin reddening
- •
- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- •
- with any other drug containing acetaminophen (prescription or nonprescription). 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
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- diabetes
- •
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain or nasal congestion gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
- •
-
new symptoms occur
These could be signs of a serious condition.
CloseKeep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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)
Closeadults and children 12 years and over
- •
- take 2 caplets every 4 hours
- •
- swallow whole – do not crush, chew or dissolve
- •
- do not take more than 10 caplets in 24 hours
children under 12 years
ask a doctor
- Inactive ingredients
acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Close - Questions or comments?
- Principal Display Panel
Compare to the active ingredients in Tylenol® SINUS + HEADACHE
Acetaminophen
CONGESTION AND PAIN
CAPLETS
Acetaminophen – Pain reliever / Fever reducer
Phenylephrine HCl – Nasal decongestant
Relieves: Sinus Headache, Sinus Pressure & Nasal Congestion
Actual Size
For Adults
24 CAPLETS
with cool Blast Flavor
NON-DROWSY
DAYTIME
Close - INGREDIENTS AND APPEARANCE
ACETAMINOPHEN CONGESTION AND PAIN
acetaminophen, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6760 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color GREEN Score no score Shape OVAL Size 16mm Flavor VANILLA (menthol) Imprint Code L272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6760-24 12 in 1 CARTON 01/15/2007 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/15/2007 CloseLabeler - Major Pharmaceuticals (191427277)
