Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet
- NDC Code(s): 69729-322-27, 69729-322-37, 69729-322-38
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 10, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
- Do not take more than directed - see overdose warning
- swallow whole; do not crush, chew or dissolve
- do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use
INDICATIONS & USAGE
Temporarily relieves these symptoms of hay fever or other respiratory allergies:
- Nasal congestion
- Sinus congestion & pressure
- Runny nose and sneezing
- Minor aches & pain
Temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus opening and passages
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take :
- more than 6 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs contains acetaminophen
- 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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 doctor promptly
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 you have:
- Liver disease
- High blood pressure
- Thyroid disease
- Trouble urinating due to enlarged prostate gland
- A breathing problem such as emphysema or chronic bronchitis
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.
Stop use and ask a doctor if:
You get nervous, dizzy, or sleepless
Pain, nasal congestion, or cough gets worse or lasts more than 7 days
Fever gets worse or last more than 3 days
Redness or swelling is present
New symptoms occur
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.
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white Score no score Shape ROUND (BICONVEX) Size 13mm Flavor Imprint Code S78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-322-27 2 in 1 POUCH; Type 0: Not a Combination Product 08/26/2019 2 NDC:69729-322-37 12 in 1 POUCH; Type 0: Not a Combination Product 08/26/2019 3 NDC:69729-322-38 144 in 1 POUCH; Type 0: Not a Combination Product 08/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/26/2019 Labeler - OPMX LLC (029918743)