Label: SINUS CONGESTION AND PAIN- acetaminophen and phenylephrine hydrochloride capsule
- NDC Code(s): 49035-558-22
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each gelcap)
Acetaminophen 325 mgClose
Phenylephrine HCl 5 mg
- for the temporary relief of:
- sinus congestion and pressure
- minor aches and pains
- nasal congestion
- helps decongest sinus openings and passages
- promotes sinus drainage
- helps clear nasal passages
- for the temporary relief of:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 gelcaps 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
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.
Ask a doctor before use if
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse of lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 12 gelcaps in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
croscarmellose sodium, croscpovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxideClose
Call toll free: 1-800-426-9391Close
- Principal Display Panel
SEE NEW WARNINGS INFORMATION
Compare to Tylenol® Sinus Congestion & Pain Daytime Active Ingredients*
Pain Reliever, Nasal Decongestant
• Headache - Acetaminophen
• Sinus pressure, nasal congestion - Phenylephrine HCl
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-558 Route of Administration ORAL DEA Schedule 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score score with uneven pieces Shape CAPSULE Size 19mm Flavor Imprint Code 44;558 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-558-22 1 in 1 CARTON 1 48 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 03/17/2008 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(49035-558) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(49035-558)