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- NDC Code(s): 68210-4190-1
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
If you are a consumer or patient please visit this version.
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- Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Antihistamine
Nasal decongestant
- Uses
• temporarily relieves these symptoms of hay fever and the common cold:
• runny nose
• sneezing
• headache
• minor aches and pains
• nasal congestion
• temporarily relieves these additional symptoms of hay
• fever:
• itching of the nose or throat
• itchy, watery eyes - 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
• 3 or more alcoholic drinks every day while using this product
• with other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• blisters
• rash
• skin reddening
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.
• with any other product containing diphenhydramine, even one used on skin
• 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
• glaucoma
• thyroid disease
• heart disease
• diabetes
• high blood pressure
• difficulty in urination due to enlargement of the 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
• taking sedatives or tranquilizers - When using this product
• do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• avoid alcoholic beverages - 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 or lasts more than 3 days
• redness or swelling is present - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
• do not use more than directed
• adults and children 12 years and over
• take 2 caplets every 4 hours
• do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor - Other information
• store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)
- Inactive Ingredients
microcrystalline cellulose, pregelatinized starch, croscarmellose sodium,
polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake - Questions or comments?
1-888-333-9792
- SPL UNCLASSIFIED SECTION
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- SPL UNCLASSIFIED SECTION
- label and carton
label
carton
- INGREDIENTS AND APPEARANCE
ALLERGY PLUS SINUS HEADACHE
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, POTATO (UNII: 8I089SAH3T) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) PYRROLIDINE (UNII: LJU5627FYV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code S504 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4190-1 1 in 1 CARTON 11/11/2021 1 12 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/11/2021 Labeler -Spirit Pharmaceuticals LLC(179621011)
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More Info on this Drug
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View Labeling Archives for this drug
ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated
Number of versions: 3
Published Date (What is this?) | Version | Files |
---|---|---|
Dec 11, 2023 | 4 (current) | download |
Nov 30, 2022 | 3 | download |
Nov 15, 2021 | 2 | download |
RxNorm
ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1233575 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | PSN |
2 | 1233575 | acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD |
3 | 1233575 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | SY |
4 | 1233575 | APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY |
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ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated
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NDC Codes
ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 68210-4190-1 |